Shows
Making MedTech Happen with RQM+Live! #89 – Compliance for EU Market Access with BSI, Brabners, and RQM+This panel was recorded September 18, 2025. We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from...
2025-11-031h 02Making MedTech Happen with RQM+Live! #87 – Built for Her: Funding, fixing, and fueling the next era of MedTechThis panel was recorded 20 March 2025. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.Women’s health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations...
2025-04-081h 01
Making MedTech Happen with RQM+Weekly Watch #51 (AI-Generated, Subscribe On LinkedIn)This is an experiment and AI-generated audio version of edition #51 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.A new edition of the RQM+ Weekly Watch is published on LinkedIn every Tuesday.--📲 Follow RQM+ on LinkedIn.📩 Subscribe to the RQM+ Weekly Watch.💼 Check out our open positions.📚 ...
2025-04-0222 min
Making MedTech Happen with RQM+Weekly Watch #48 (AI-Generated, Subscribe On LinkedIn)This is an experiment and AI-generated audio version of edition #48 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter here. A new edition is published to LinkedIn every Tuesday.--📲 Follow RQM+ on LinkedIn.📩 Subscribe to the RQM+ Weekly Watch.💼 Check out our open positions.
2025-03-1129 min
Making MedTech Happen with RQM+Weekly Watch #47 (AI-Generated, Subscribe On LinkedIn)This is an experiment and AI-generated audio version of edition #47 of our weekly LinkedIn newsletter, the RQM+ Weekly Watch.This summary is automatically generated and should not be considered a direct statement from RQM+. While we strive for accuracy, please know this summary may contain errors. It's also only a brief snapshot of the material from this week's LinkedIn newsletter, which contains much more information.For the complete picture, please see the full newsletter here. A new edition is published to LinkedIn every Tuesday.--📲 Follow RQM+ on LinkedIn.📩 Subscribe to the RQM+ Weekly Watch.💼 Check out our open positions....
2025-03-0617 minMaking MedTech Happen with RQM+Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMDThis panel was recorded 30 January 2025.Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.Join part two of our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.Our panel of industry experts will provide clear, implementable guidance on:
2025-02-121h 13Making MedTech Happen with RQM+Live! #85 – Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMDThis panel was recorded 12 December 2024. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.
Thank you for tuning in. 🙏
As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.
Join our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.
Our panel of industry experts will provide clear, implementable guidance on:
Practical strategie...
2024-12-191h 03Making MedTech Happen with RQM+Michael Louis, Chemist II (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our run of 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interviews with our Jordi Labs, an RQM+ Company team members continues with Christine Santagate, RAC chatting with Senior Chemist II and supervisor of our gas and liquid chromatography teams, Michael Louis, Ph. D.
Listen in to hear how Mike became a 𝗿𝗲𝘀𝗽𝗲𝗰𝘁𝗲𝗱 𝗹𝗲𝗮𝗱𝗲𝗿 𝗮𝗻𝗱 𝗺𝗲𝗻𝘁𝗼𝗿, known for his extensive chemistry expertise and collaborative approach. 👨🔬
In the interview Mike shares:
✔️ His journey from University of Massachusetts Amherst to University of New Hampshire, and finally...
2024-10-0805 minMaking MedTech Happen with RQM+Best Practices In AE Reporting In Clinical Trials – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🚨 Watch our newest video to learn best practices for 𝗮𝗱𝘃𝗲𝗿𝘀𝗲 𝗲𝘃𝗲𝗻𝘁 𝗿𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀.
Manager of Safety Management Melanie Miller reveals:
📊 AE definitions for medical devices vs. drugs
🌍 Global reporting requirements and timelines
📋 Minimum data set for reportable AEs
🔬 Reporting differences across study types
Elevate your clinical trial expertise with RQM+ (this is the 21st video in our clinical trials-specific video series this year) and ensure regulatory compliance.
2024-10-0213 minMaking MedTech Happen with RQM+Live! #82 – MDR and IVDR Amendments: Strategies for Supply Interruption ComplianceThis presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions!
We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com.
Thank you for tuning in. 🙏
The recently published Regulation (EU) 2024/1860 amends the EU Medi...
2024-09-261h 07
Making MedTech Happen with RQM+Anthony Grice, Chemist III (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chemist at Jordi Labs for over a decade!
Discover how "Ant" became our go-to 𝗖𝗦𝗜 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝘆 🕵️♂️, solving complex problems with creativity. Ant shares:
✔️ His journey from the UK to becoming a polymer chemistry expert
✔️ The excitement of tackling diverse challenges in analytical chemistry
✔️ His experience with GPC and its applications in #medicaldevices
🔨 Some unconvent...
2024-09-2508 minMaking MedTech Happen with RQM+How a CRO Helps with Data Management In Clinical Trials – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗖𝗥𝗢𝘀 𝗶𝗻 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁.
Noel covers:
🤝 The importance of partnership between CROs and sponsors
🏆 Key performance and quality indicators across all trial phases
🔍 Independent quality review processes
📚 Leveraging standardized libraries and best practices
🎯 Tailoring services t...
2024-09-1114 minMaking MedTech Happen with RQM+Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🎉 The data management party continues!
Part 2 of our clinical trial data management series is here! Jaishankar Kutty, Ph.D. welcomes back Senior Director of Data Operations, Noel Keegan, to dive into the 𝗺𝗮𝗶𝗻𝘁𝗲𝗻𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗰𝗹𝗼𝘀𝗲𝗼𝘂𝘁 𝗽𝗵𝗮𝘀𝗲𝘀 of clinical trial data management.
In this discussion, Noel covers:
📊 Data validation activities post-database build
🔄 Managing external data from core labs, imaging, and safety
📈 Sharing validat...
2024-09-0314 minMaking MedTech Happen with RQM+Data Management In Clinical Trials (Setup Phase) – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🎉 It's a data management party – you in?
Our team had a ton of fun recording the newest video in our clinical trial video series and it's now available. Jaishankar Kutty, Ph.D. speaks with Senior Director of Data Operations, Noel Keegan, about 𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀, specifically focusing on the study setup phase.
More particularly, Noel covers selecting appropriate electronic data capture systems, database setup timelines and risks, and considerations for d...
2024-08-2814 min
Making MedTech Happen with RQM+Joshua Nott, Technical Program Lead (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthusiastic Jordi Labs Technical Program Lead Joshua Nott. 👋
🎥 Hear how Josh's journey from biochemistry to analytical chemistry led him to excel in customer service and technical problem solving. Josh also shares:
✔️ His transition into project management
✔️ How he builds rapport with clients
✔️ His experienc...
2024-08-2708 minMaking MedTech Happen with RQM+Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2) – MedTech CRO: Clinical Trial Execution Series
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.
In these two videos (this is video 2) specific to site selection and monitoring, RQM+ experts reveal:
Key considerations for selecting ideal clinical partners
Red flags to watch out for during site selection
Best practices...
2024-08-1609 minMaking MedTech Happen with RQM+Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2) – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials.
In these two videos (this is video 1) specific to site selection and monitoring, RQM+ experts reveal:
Key considerations for selecting ideal clinical partners
Red flags to watch out for during site selection
Best practices for ef...
2024-08-1510 minMaking MedTech Happen with RQM+Live! #81 (with FDA) – Advancing Health Equity with IVDs & Medical DevicesThis presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com.
Thank you for tuning in. 🙏
RQM+ welcomes Michelle Tarver, M.D., Ph.D., Acting CDRH Director and Deputy Center Director for...
2024-08-141h 06Making MedTech Happen with RQM+Site Monitoring In Clinical Trials – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🔄 We recently covered Site Selection In Clinical Trials and we're coming right back to share a new video on 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴.
For 𝗦𝗶𝘁𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀, Jaishankar Kutty, Ph.D. is rejoined by Senior Director of Clinical Operations, Brandy Chittester, and also joined by Director of Clinical Operations, Martin Schulz.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁:
◽ Balancing on-site and remote monitoring based on risk assessment
◾ Location-specific considerations in site management
◽ Strateg...
2024-08-0213 minMaking MedTech Happen with RQM+Site Selection In Clinical Trials – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🆕 Our newest video: 𝗦𝗶𝘁𝗲 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀.
Senior Director of Clinical Operations Brandy Chittester and Study Start-Up Associate Elicia Dellinger join Jaishankar Kutty, Ph.D. to explore the process.
𝗧𝗵𝗶𝘀 𝘃𝗶𝗱𝗲𝗼 𝗰𝗼𝘃𝗲𝗿𝘀:
Key factors influencing site selection
The step-by-step process of identifying and assessing potential sites
Balancing communication between sponsors, CROs, and trial sites
Strategies to mitigate enrollment risks
Anyone involved with clinical trial planning and execution will benefit from this one, wit...
2024-07-3113 minMaking MedTech Happen with RQM+Live! #80 – Beyond EtO: New EPA Regulations and Sterilization AlternativesThis was recorded 18 July 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com.
Thank you for tuning in. 🙏
The recently finalized EPA rule on ethylene oxide (EtO) emissions requires significant changes for sterilization fa...
2024-07-1847 minMaking MedTech Happen with RQM+Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.
𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:
◽ Determining the regulatory pathway for your combination product
◾ Addressing regulators' primary concerns in submissions
◽ Overcoming clinical trial challenges unique to combination products
◾ Key learnings from real-world cas...
2024-07-1714 minMaking MedTech Happen with RQM+RQM+ Consultant RoundtableThis conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients.
Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance.
Whether you're a professional simply interested in the field or a manufacturer interested in potentially leveraging consultant expertise, this conversation offers valuable perspectives.
Chapters
2024-07-1625 minMaking MedTech Happen with RQM+Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Combination Device Clinical Trials: Strategy & Tactics
Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.
Key topics covered:
Definition and examples of combination devices
Regulatory pathways in the US and EU
Product devel...
2024-07-1119 minMaking MedTech Happen with RQM+Key Aspects of Medical Device Clinical Trial Design (2/2) – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀
Part 2 of our key aspects of device trial design covers:
Overcoming key barriers in trial design
Balancing statistical significance with clinical relevance
Strategies for faster enrollment and reduced dropouts
🎥 Cari Kniola, Guido Rieger, Rolf Hövelmann, and Jaishankar Kutty, Ph.D. share valuable insights to optimize your next clinical trial.
🔑 Key takeaway? 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. Learn how RQM+ leverages cross-functional expertise to design trials that deliver meaningful results...
2024-07-0812 minMaking MedTech Happen with RQM+Key Aspects of Medical Device Clinical Trial Design (1/2) – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮)
Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hövelmann.
This video covers...
𝗖𝗿𝘂𝗰𝗶𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗙𝗮𝗰𝘁𝗼𝗿𝘀:
– Addressing and mitigating confounding factors, biases, and variations
– Ensuring treatment effects can be isolated
𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵:
– The importance of considering end goals for product and study
– Incorporating clinical expertise from the start
2024-07-0112 minMaking MedTech Happen with RQM+Risk Management In Clinical Trials – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
🛡️ 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀
Senior Director of Clinical Operations Brandy Chittester and Senior Diretor of Project Management Cari Kniola join Jaishankar Kutty, Ph.D. to discuss...
𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗥𝗶𝘀𝗸 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀:
– Identifying and mitigating risks in trial design, budget, quality, timelines, site selection, enrollment dynamics, and safety
𝗞𝗲𝘆 𝗥𝗶𝘀𝗸𝘀 𝗧𝗼 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿:
– The responsibility of risk management
– The role of project managers and study teams
𝗘𝘅𝗲𝗰𝘂𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗥𝗲𝗮𝗹-𝗪𝗼𝗿𝗹𝗱 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀:
2024-06-2714 minMaking MedTech Happen with RQM+Would you like to get reimbursed? – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
💰 𝗪𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗱?
Securing regulatory approval is just the beginning. The newest video in our educational clinical trials series covers the intricacies of reimbursement strategy and its critical role in your product's success.
Daniel Lace, MD, CPE, FAAPL joins Jaishankar Kutty, Ph.D. to discuss:
𝗧𝗵𝗲 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗦𝘁𝘂𝗱𝘆 𝗗𝗲𝘀𝗶𝗴𝗻:
– How study design impacts reimbursement po...
2024-06-2514 minMaking MedTech Happen with RQM+Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies?
❓ What 𝘁𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀 ensure success?After our first two strategic videos, our educational video series on clinical trials continues with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀.
Frank Maier, Director of Project Management within RQM+ Clinical Trial Services, joins Jaishankar Kutty, Ph.D. to walkthrough tactical specifics of first-in-human (FIH) clinical investigations.
𝗪𝗮𝘁𝗰𝗵 𝗮𝗻𝗱 𝗹𝗲𝗮𝗿𝗻:
➡️ The steps for executing successful FIH studie...
2024-06-1211 minMaking MedTech Happen with RQM+Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively?
🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟮/𝟮) answers these questions. Once again, Jaishankar Kutty, Ph.D. is back with VP of Strategic Regulatory Affairs Sew-Wah Tay.
𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻:
📌 The importance of CGMP principles and full traceability for FIH devices
📌 Managing device iterations in a 10-15 patient FIH study
📌 Key considerations for site and physician selection across different geographies...
2024-06-1012 min
Making MedTech Happen with RQM+Scott Edwards, Managing Director | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
"Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way."
Scott Edwards, Managing Director at RQM+, shares his extensive industry experience and personal journey in our latest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview.
𝗦𝗼𝗺𝗲 𝗼𝗳 𝗦𝗰𝗼𝘁𝘁'𝘀 𝗔𝗱𝘃𝗶𝗰𝗲?
🔘 Establishing solid relationships and fostering a strong culture of quality are crucial in the medical device industry.
🔘 Understanding the FDA's perspective an...
2024-05-0813 min
Making MedTech Happen with RQM+Samantha Howard, Study Director (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical devices, we're thrilled to showcase one of Jordi's shining stars in our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series: Meet Samantha Howard, Study Director! 🌟
As an influential voice within Jordi Labs, an RQM+ company, Samantha's deep knowledge and exceptional communication skills have made her a go-to resource for clients seeking solutions to complex problems. Her work directly...
2024-04-2911 min
Making MedTech Happen with RQM+Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year CareerWhile we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here.
In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professional as you'll 𝘦𝘷𝘦𝘳 find in regulatory affairs and as she embarks on her well-deserved retirement, she generously takes the time to impart her wisdom and provide guidance to those aspiring to build a successful c...
2024-04-1219 min
Making MedTech Happen with RQM+Adam Eason, Senior Study Director (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving complex scientific problems.
🔬 His diverse experience includes drug development, environmental chemistry, and polymer chemistry testing. In the interview, you'll hear just how important 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻 and 𝗽𝗿𝗼𝗯𝗹𝗲𝗺-𝘀𝗼𝗹𝘃𝗶𝗻𝗴 𝘀𝗸𝗶𝗹𝗹𝘀 are in this role as Senior Study Director.
👥 Sharing achievements with this team? 𝗧𝗵𝗮𝘁'𝘀 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁, 𝘁𝗼...
2024-03-2610 min
Making MedTech Happen with RQM+Noel Keegan, Sr. Director, Data Operations (Clinical Trials) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-thinking approach has elevated our clinical trial methodologies and consistently ensured the success and integrity of our trials.Starting with a pharmacology degree and skills a...
2024-03-2110 min
Making MedTech Happen with RQM+Kaitlin Lerner, Director of Operations, Lab Services (Jordi Labs) | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team.
In this week's Excellence Spotlight interview, she shares her fascinating journey with Lab Services Chief of Staff, Christine Santagate, RAC (welcome to the Excellence Spotlight, Christine 👋).
🎓 With roots deeply planted in analytical a...
2024-03-1311 min
Making MedTech Happen with RQM+Anastassia Young, Senior Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA related to Adverse Event (AE) Reporting. Today, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight. 🔦
A quick glance at what Anastassia brings to RQM+ and our clients:
🔍 Technical Savvy and Storytelling: Her impressive background in science...
2024-03-0511 min
Making MedTech Happen with RQM+Song Seto, Principal, Regulatory and Quality Practice | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/QA practice.
With a rich background from University of California, Berkeley and Georgia Institute of Technology, as well as experience as a lead reviewer at the FDA, Song's journey is impressive... and this is exactly the experience and capability she brings to RQM+ clie...
2024-02-2709 min
Making MedTech Happen with RQM+Taryn Meade, Director of Biological Evaluation Consulting | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview!
Jaishankar Kutty, Ph.D. describes her as "elegant, talented, quietly confident, and always understated," but we're not going to be understated here! It's time to deservedly shine the spotlight on Taryn and what she brings to RQM+ and our lab clients.
With a decade in medical devic...
2024-02-1913 min
Making MedTech Happen with RQM+Garrett Jeffries, Principal, Clinical and Post-Market Practice | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Excellence Spotlight interview.
A snapshot of Garrett’s background and impact to RQM+ clients:
🔬 Bioengineering Brilliance: Garrett has built a career that blends engineering expertise with clinical savvy. His work has spanned the full spectrum of device development, and notably embodies a holistic ap...
2024-02-1313 min
Making MedTech Happen with RQM+Elizabeth Starling, Senior Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Senior Consultant at RQM+. Hear her story in our newest Excellence Spotlight interview.
Just a snippet of what sets Elizabeth apart:
🧠 Deep Regulatory Knowledge: With a background that combines legal savvy with regulatory expertise, Elizabeth can dissect the most intricate compliance challenges and offe...
2024-02-0612 min
Making MedTech Happen with RQM+Laurie Pettit, Senior Manager, RA/QA Consulting Services | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey in our newest Excellence Spotlight interview.
Here's why Laurie is an invaluable asset to RQM+ and our clients:
🌍 Global Regulatory Savvy: From her biology beginnings to navigating the complex pathways of international regulations, Laurie's career spans many roles and geographies. Her deep understanding of globa...
2024-01-3013 minMaking MedTech Happen with RQM+What makes a good EU MDR program from a maintenance perspective? | MedTech MomentsMedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance.
What makes a good EU MDR program from a maintenance perspective?
We answered this question in RQM+ Live! #72, featuring:
Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
Brian Dahl – Vice President of Quality and Regulatory, Starkey Hearing
Jaishankar Kutty, Ph.D. Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
🎥⏯️🕗 Watch the entire panel and see the...
2024-01-2910 min
Making MedTech Happen with RQM+Nicholas Wilson, Principal, Clinical and Post-Market Practice | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Meet Nicholas Wilson, Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview.What makes Nicholas special? A lot! Please listen to his story in the interview, but here are just a few reasons RQM+ clients love working with Nicholas:
🌍 Global Expertise: From his beginnings in New Zealand to significant stints in Sydney, Barcelona, Abu Dhabi, Zurich, and the UK, Nichol...
2024-01-2614 min
Making MedTech Happen with RQM+Alexia Haralambous, Senior Principal | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
2️⃣ things we're excited about today...
1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former FDA-er Alexia Haralambous – a mastermind in spinal devices and global regulatory affairs.
2. Alexia has just been added as a panelist to next week's RQM+ Live! show: Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers. Will you join? If interested, please RSVP at the link in the...
2024-01-1014 min
Making MedTech Happen with RQM+Niki Caporali Spaniel, Principal, CPMP, Practice Manager | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellence Spotlight interview with Niki Caporali Spaniel, RAC.
Niki's journey blends a deep-seated passion for healthcare with an extremely impressive command over regulatory strategies, reflecting a career built on empathy, expertise, and a commitment to advancing MedTech.
What does Niki bring to the ta...
2024-01-0214 min
Making MedTech Happen with RQM+Lindsay Wright, Senior Consultant / Capability Manager | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎄 This week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capability Manager, Lindsay Wright.
A snapshot of what Lindsay brings to RQM+ and our clients 👇
Biomedical Engineering and Mechanical Engineering Ingenuity: Lindsay started her journey at the University of Pittsburgh, first excelling in bioengineering, then going further, receiving her master's degree in mechanical engineering.
...
2023-12-2012 min
Making MedTech Happen with RQM+Rostislav Stoykov, Principal RA/QA | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Today's Excellence Spotlight features Principal RA/QA Rostislav Stoykov. With a strong foundation in biomedical and clinical engineering, Rostislav has masterfully navigated the complex regulatory landscape and made significant contributions in the medical device industry.
Highlights from his conversation with Jaishankar Kutty, Ph.D.:
🎓 Biomedical and Clinical Engineering Roots: Rostislav’s journey began with a dual degree in biomedical and clinical engineeri...
2023-12-1214 min
Making MedTech Happen with RQM+Torrie DeGennaro, Principal | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ The plus is the people at RQM+ and today's Excellence Spotlight features Torrie DeGennaro, a star in biomedical engineering and quality assurance at RQM+. Torrie's innovative approach to PMCF data collection has been pivotal in securing MDR certification for numerous legacy devices. She's also a key contributor to our AI clinical evidence platform, Fern.ai.
Highlights from her conversation with Jaishankar Kutty, Ph.D.:
2023-12-0410 min
Making MedTech Happen with RQM+Richard Freeman, Director of Global Audit Practice | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Today's Excellence Spotlight proudly features our Director of Global Audit Practice, Dr. Richard Freeman. Richard's journey from academia to industry has made him a standout expert in product development, process development, and quality systems, to name just a few.
Highlights from Richard's interview with Jaishankar Kutty, Ph.D.:
🧪 Science and Innovation: Beginning his career with a strong focus on chemistry, Richard's passi...
2023-11-2913 min
Making MedTech Happen with RQM+Andrew Lakey, Senior Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant Andrew Lakey, Ph.D. Andrew is a multidisciplinary scientist whose career spans academia, industry, and notified body experience, making him a vital asset to our IVD team.
Key insights from our interview:
🔬 From Forensics to IVDs: Andrew's journey began with forensic science, leading to a deep dive into microfluidics and nanotechnology. His transition to IVD diagnostics showcases his adaptability and de...
2023-11-2109 min
Making MedTech Happen with RQM+Brandy Chittester, Senior Director of Clinical Operations | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
💬 "Stay ready so you don't have to get ready." – Brandy Chittester, Senior Director of Clinical OperationsIn a new Excellence Spotlight interview, we're thrilled to talk with Brandy Chittester, a key figure in clinical research at RQM+. Brandy skillfully bridges the gap between technical expertise and operational excellence.
Some highlights:
🔍 The Journey from Engineering to Clinical Research: Starting her career in mechani...
2023-11-1510 min
Making MedTech Happen with RQM+Hrishikesh Gadagkar, Senior Principal Engineer | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎙️ Our Excellence Spotlight series proudly showcases the technical excellence personified by our team. Senior Principal Engineer, Hrishikesh Gadagkar, Ph.D., stands as a paramount example of this dedication.
Three highlights from our newest interview:
🛤️ Tech Trailblazer in Med Devices:
Leading from the front in areas ranging from diagnostic imaging to wearable technology, Rishi has a track record of steering complex pro...
2023-11-0714 min
Making MedTech Happen with RQM+Cari Kniola, Senior Director of Project Management | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
➕ Meet Senior Director of Project Management Cari Kniola in our newest Excellence Spotlight interview 👇
Cari navigates clinical trials with expertise and commitment. Her 26+ years of experience in clinical research elevates the capacity of RQM+ to serve clients and drive innovation. Cari's journey into this field is as fascinating as her work, transitioning from a background in veterinary technology to becoming a linchpin in advanci...
2023-11-0115 minMaking MedTech Happen with RQM+Live! #73 – October Overview: Essential Insights from an Eventful Month in MedTechThis show was recorded 26 October 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager joined RQM+ experts for a special edition of our Live! show, all about the month's industry events! This session brings together insights from an array of events our team attended throughout October, such as the RAPS Convergence and The MedTech Conference (AdvaMed). We've soaked in knowledge, experiences, and taken note of indust...
2023-10-271h 02
Making MedTech Happen with RQM+Ethan Elshoff, Senior Project Manager | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🎙️ Our Excellence Spotlight series and host Jaishankar Kutty, Ph.D. are back this week with a feature on RQM+ Senior Project Manager, Ethan Elshoff, MPH, MBA.
Three standout points from the interview:
📊 Mastery in Business Analytics and Healthcare Strategy: Ethan possesses a unique combination of business analytics, healthcare strategy development, and project management expertise. His educational foundation, with a Master's in both Public...
2023-10-1910 min
Making MedTech Happen with RQM+Catherine Kang, Principal Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Today we're shining the spotlight on Principal Consultant Dr. Catherine Kang! We love this interview and hope you'll listen. With an engineering foundation, deep roots in biomaterials, cell biology, and tissue engineering, Catherine's expertise doesn't stop there. She stands tall in neuroscience, medical writing, and especially in combination products – merging drugs and devices.
🔍 Three highlights about Catherine...
From Research to Regulatory Master...
2023-10-1014 min
Making MedTech Happen with RQM+Kevin Rowland, Director of R&D | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
Meet RQM+ Director of R&D (and "detective" 🕵️) Kevin Rowland in our new Excellence Spotlight...
🔍 Two highlights about Kevin...
True Mastery in Analytical Chemistry:Kevin’s foundation in engineering and chemistry allows him to employ high-end instrumentation and sophisticated methods to tackle the most challenging projects in analytical chemistry, ensuring the accuracy and reliability of results in highly regulated tests.
Develo...
2023-10-0209 minMaking MedTech Happen with RQM+Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain ComplianceThis show was recorded 28 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
The extension of the EU MDR compliance timeline offers a reprieve for medical device manufacturers, but this extended window comes with its own set of challenges and conditions. As the interim deadlines approach, it’s critical for manufacturers to fully understand their obligations and the ramifications of failing to meet them.
In this high-impact panel discussion, thought leaders...
2023-09-2859 min
Making MedTech Happen with RQM+Diane Cox, Principal Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients.
🌟 The plus is the people at RQM+ and our Excellence Spotlight series celebrates them... as well as the significant impact they have on our clients.
This week we're delighted to feature Principal Consultant Diane Cox, whose expertise in FDA, ISO, risk, and compliance within the medical device and IVD industries is an invaluable asset to RQM+ and the clients we serve.
We h...
2023-09-2608 minMaking MedTech Happen with RQM+Live! #71 – Material Matters: Navigating Risks and Strategies for Improving Medical Device SafetyThis show was recorded 21 September 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for tuning in! 🙏
We all know: ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers.
One of the key challenges in achieving this goal is selecting and managing materials effectively, while maintaining supplier controls and identifying opportunities for proactive design changes.
In this panel discussion, experts in medical devic...
2023-09-2253 min
Making MedTech Happen with RQM+Pooja Roychoudhury, Senior Principal Engineer | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🌟 Today, we’re delighted to present another episode of our Excellence Spotlight series, featuring RQM+ Senior Principal Engineer, Pooja Roychoudhury!
🛠 With over 12 years (!) at RQM+, Pooja is a tour de force in design quality engineering, risk management, usability, 𝘢𝘯𝘥 𝘴𝘰 𝘮𝘶𝘤𝘩 𝘮𝘰𝘳𝘦, as you'll hear in the clip. Her multi-disciplinary educational background, including engineering and an MBA, has set the stage for her to be a role model in what we call the six C's of Learning – from critical thinking to customer success.
💕 But what truly sets Pooja apart are the life-c...
2023-09-0608 min
Making MedTech Happen with RQM+BONUS Excellence Spotlight with Case Studies — Jon Gimbel, Vice President of TechnicalOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel. Here's a link to Jon's original feature if you haven't seen it.
While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertise at RQM+ and our dedication to helping clients through a multitude of challenges, including navigating the complex landscape of regu...
2023-08-2206 min
Making MedTech Happen with RQM+Bethany Chung, Principal Regulatory Scientist | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
🌟 Today as part of our Excellence Spotlight video series we're celebrating RQM+ Principal Regulatory Scientist, Bethany Knorr Chung, PhD, RAC!
🔢 Bethany is a driving force behind our clinical and post-market operations group. With an exceptional background in math, biology, and biomedical engineering, she's truly a maestro of all things quantitative.
👪 Bethany's journey is a testament to her unwavering commitment to excellence personally and professionally. Following a brief hiatus to prioritize her family, she made a powerful comeback to the workfo...
2023-08-0308 minMaking MedTech Happen with RQM+Live! #69 – Insider Perspectives: Mastering EU Compliance with BSI's Richard Holborow and RQM+'s Amie SmirthwaiteThis show was recorded 27 July 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
Listen to a captivating and informative conversation aiming to help you master EU compliance, where BSI's Global Head Clinical Compliance Richard Holborow and RQM+'s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together and address current challenges and provide valuable insights on navigating the complex landscape of EU regulations.
This conversation will:
Empower m...
2023-07-281h 00
Making MedTech Happen with RQM+Jon Gimbel, Vice President of Technical | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
Thanks for all the warm messages and feedback in response to our first Excellence Spotlight two weeks ago with Eila Pattee, MS, MLS(ASCP), RAC. Now it's time for round two!
🌟 In this latest episode, we're delighted to introduce none other than Vice President of Technical, Jonathan Gimbel, Ph.D. A problem solver through and through, this clip goes deep into what's made Jon successful. We think there are some incredible insights to learn from Jon's journey and apply to your...
2023-07-1909 min
Making MedTech Happen with RQM+Eila Pattee, Principal Consultant | Excellence SpotlightOur Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees.
At RQM+, 𝐭𝐡𝐞 𝐩𝐥𝐮𝐬 𝐢𝐬 𝐭𝐡𝐞 𝐩𝐞𝐨𝐩𝐥𝐞.
We've been saying it, but now it's time to 𝒔𝒉𝒐𝒘 𝒚𝒐𝒖. 🎥
We're thrilled to unveil a new video series shining a spotlight on the outstanding individuals who help keep our clients moving forward!
🔦 Introducing the Excellence Spotlight series, where we celebrate exceptional talents and showcase the remarkable journeys and achievements of employees. We're starting with Principal, Eila Pattee, MS, MLS(ASCP), RAC.
🏅 We dive into Eila's journey at RQM+ and how she's made a lasting impact in the MedTech industry.
Through this series, we aim to inspire...
2023-07-0709 minMaking MedTech Happen with RQM+Live! #67 – Beyond Indications: Managing Off-Label Use for Safety and ComplianceThis show was recorded 25 May 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center. Thank you for listening!
This panel discussion is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. However, one of the key challenges manufacturers face is how to identify and handle off-label use, especially with the...
2023-05-251h 01Making MedTech Happen with RQM+Live! #65 – How AI is Revolutionizing MedTech: Current and Future ApplicationsThis show was recorded 23 March 2023 and can be viewed on our website here. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center.
Artificial Intelligence (AI) has the potential to revolutionize healthcare and the medical technology industry, with the ability to assist in clinical decision-making, improve patient outcomes, accelerate speed to market and improve efficiency. In this RQM+ Live! show, leaders from RQM+ and Giotto.ai will explore the current and future applications of AI in MedTech, including the use of AI in medic...
2023-03-2446 min
Making MedTech Happen with RQM+Live! #64 – The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory RequirementsThis is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing.
The expert...
2023-02-171h 01Making MedTech Happen with RQM+Proactive PMCF Data with Economy and Expediency (#1) | MedTech Voices#MedTechVoices continues with the first episode of a brand new mini series: Proactive PMCF Data with Economy and Expediency (#1).
This series is about looking at the successes that RQM+ has had over time in collecting data of sufficient quality and quantity for legacy devices across all device classifications... and sharing our learnings and strategies along the way.
For the first video/audio, Jaishankar Kutty, Ph.D. is joined by Niki Caporali Spaniel, RAC and Torrie DeGennaro.
Our current plan for future episodes in this mini series:
Focused on notified body feedback and...
2022-12-1309 minMaking MedTech Happen with RQM+Live! #61 – Medical Device Software: Top Deficiencies and Requests for Additional Info from FDA and Notified BodiesThis is audio from RQM+ Live! #61, recorded 13 October, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Each year RQM+ supports hundreds of FDA 510(k)'s and EU technical documentation files for either medical devices containing software or stand-alone software devices. In this show our regulatory experts will discuss both FDA and EU deficiencies and additional information requests associated with software (real case studies), as well as best practices and solutions to avoid these pain points in your submissions.
2022-10-141h 01Making MedTech Happen with RQM+Live! #60 – RAPS Convergence Takeaways: RQM+ event speakers share their biggest surprises and learningsThis is audio from RQM+ Live! #60, recorded 22 September, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We also answer your questions in the process!
This RQM+ Live! show discusses the biggest takeaways and surprises from this year's RAPS Convergence. We cover at least a little bit of...
2022-09-2657 minMaking MedTech Happen with RQM+Live! #58 –Regulatory Landscape of Companion Diagnostics (CDx) in the EUThis is audio from RQM+ Live! #58, recorded 14 July, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Companion diagnostics (CDx) are critical to patient safety when taking potentially life-saving drugs, e.g. in oncology. CDx can help identify which patients will benefit from a specific drug treatment to improve patient outcomes and identify those patients who have an increased risk for serious side effects from a certain treatment. Hence, CDx are essential in the evolution of precision medicine “providing th...
2022-07-151h 07
Making MedTech Happen with RQM+Live! #57 – FDA Appeals Process (featuring panelists from Linear Health and DuVal & Associates, PA)This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product clearance/approval.
Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination...
2022-06-3058 minMaking MedTech Happen with RQM+Live! #56 – IVDR: A Notified Body Perspective (featuring Marta Carnielli of TÜV SÜD)This is audio from RQM+ Live! #56, recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for upcoming sessions in the Knowledge Center at our website.
RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates.
In this session we will discuss:
Notified body feedback in several areas from intended purpose, clinical evidence, and post...
2022-06-131h 07Making MedTech Happen with RQM+Live! #53 – Part 2: PSURs – Ready, Set, Go!This is the audio from RQM+ Live! #53, recorded 21 April, 2022. Please note we have not listed the questions asked during the show in this description because there were too many to fit! You can still see a list of them on the video recording page after filling out the form on our website here.
Our Live! discussion topic "PSURs - Ready, Set, Go!" on 24 February had record-breaking attendance, which means scheduling a sequel is a no-brainer. The discussion between the audience and our expert panelists was extremely engaging and could have gone for hours, so we're back for p...
2022-04-2658 minMaking MedTech Happen with RQM+RQM+ Live! #49 — PSURs – Ready, Set, Go!This is the audio from RQM+ Live! #49, recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list the questions covered. You can read the full description here.
Whether you've already created PSURs and are looking for ways to optimize and improve, or haven't started yet, you'll want to hear our panel of experts discuss best practices and lessons learned based upon case studies of successes, failures, and notified body feedback so far.
Questions:
2:24 -- What is your experience so far with supporting the industry with PSURs?
3:35...
2022-03-0148 minMaking MedTech Happen with RQM+RQM+ Live! #48 — Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions.
On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to our panel of former notified body leaders and industry experts. Five months have passed and our educated guess is you have even more challenges and questions to bring to...
2022-02-1546 minMaking MedTech Happen with RQM+RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?This is the audio from RQM+ Live! #47, recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions.
The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a contract with the equivalent device's manufacturer allowing access to their data. If those requirements cannot be met, the MDR states that the manufacturer must undertake cl...
2022-01-3153 minMaking MedTech Happen with RQM+RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA SubmissionsThis is the audio from RQM+ Live! #46, recorded 13 January, 2022.
As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022.
This discussion will cover the following and more:
Impact of COVID on FDA resources and submission timelines in 2021
Updates on breakthrough and new developments for innovative devices, such as the Safer Tech...
2022-01-1852 minMaking MedTech Happen with RQM+RQM+ Live! #45 — What’s new in the world of biocompatibility for medical devices?This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021.
Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, what’s on the horizon for 2022, and answers to common questions we receive like the following:
Is the biocompatibility approach different for US and EU?
When should you consider a chemical characterization approach?
How do you use exemptions for intact skin devices made of co...
2022-01-0649 minMaking MedTech Happen with RQM+RQM+ Live! #44 — Success Stories of PMCF Surveys: Strategy and ExecutionThe RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, and user populations. The survey approach has saved our clients significant amounts of money (in the millions) by avoiding the need to remove indications that would cause relabeling and rework of product in the field...
2021-12-0350 minMaking MedTech Happen with RQM+RQM+ Live! #43 — Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24This is the audio from RQM+ Live! #43, originally recorded 11 November, 2021.
MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications.
Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturers made the case for IIb classification, which was reinforced in 2018 when Team NB published a position paper stating that many spinal implants are Class IIb since they are wedges. MDCG 2021-24, in conflict with that paper, is setting off alarms across the...
2021-11-1154 minMaking MedTech Happen with RQM+Live! #42 — Unearthing IVDR with Former Notified Body Leader, Carlos GalambaThis is the audio from RQM+ Live! #42, originally recorded 28 October, 2021.
When we say RQM+ IVD Director Carlos Galamba is no stranger to the IVDR, we really mean he is no stranger to the IVDR! Carlos is not only fresh out of BSI, but was one of three technical managers developing their IVDR program. Since BSI covers close to 50% of the world’s top IVD companies, we think the perspective and experience Carlos brings to the table is absolutely invaluable.
This special edition of RQM+ Live! will be all about sharing his perspective and experience with you...
2021-10-2956 minMaking MedTech Happen with RQM+Live! #41 — Best Practices for Optimizing PMCF and Avoiding NB FindingsThis is the audio from RQM+ Live! #41, originally recorded 14 October, 2021.
Your post-market surveillance (PMS) system complying to the EU MDR was put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions!
This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and failures they’ve seen across the industry so far. While there have been and will continue to be plenty of implementation challenges, our esteemed panel has worked through comprehensive solutions and is anxious to...
2021-10-1551 minMaking MedTech Happen with RQM+Live! #40 — When should we throw the least burdensome flag or appeal an FDA decision?This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021.
This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.
Some manufacturers have strong opinions about pushing back on FDA with the argument of utilizing the least burdensome approach, while others are very hesitant to burn bridges. What’s the best approach to get the result...
2021-10-0138 minMaking MedTech Happen with RQM+Live! #39 — Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021.
The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. However, achieving certification is just the beginning. Compared to the MDD and IVDD, it will be quite challenging keeping up with all the new requirements for post-market reporting and documentation updates that these trigger. And although many IVD manufacturers are just getting started on the jo...
2021-08-2744 min
Making MedTech Happen with RQM+Live! #38 — Best Practices in Site Transfer (or Consolidation)This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021.
Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and quality associated with the transfers. Our subject matter experts have case studies, lessons learned and best practices across activities in regulatory registrations, quality systems, process validations, project management, and remediation. In this show we'll discuss solutions to some of...
2021-07-2340 min
Making MedTech Happen with RQM+Live! #37 — U.S. FDA Pathways for Innovative DevicesThis is the audio-only version of RQM+ Live! #37, originally recorded June 17, 2021.
The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that target important conditions that are not covered by the Breakthrough Devices Program and provides another mechanism to get safer treatments more quickly to the patients who need...
2021-06-1839 minMaking MedTech Happen with RQM+Event Recording — FDA Submissions in 2021: How's it going?This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discussion on our website here. RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC.
FDA Submissions in 2021: How's it going?
With a focus on FDA regulatory submissions, this panel discussion will provide context for what occurred in 2020 and early 2021, and provide forward-looking guidance and expectations for the remainder of...
2021-06-0951 min
Making MedTech Happen with RQM+Live! #36 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!This is the audio-only version of RQM+ Live! #36, originally recorded June 3, 2021.
We're back for part two! With so many questions we couldn't address during our April 22, 2021 show on this topic (available on demand), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help, so here's a second chance to learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day.
"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency...
2021-06-0343 min
Making MedTech Happen with RQM+Live! #35 — Preparing for PSURsThis is the audio-only version of RQM+ Live! #35, originally recorded May 20, 2021.
PSUR - Periodic Safety Update Report - is a new report required by the EU MDR and IVDR. Device manufacturers must have their PSURs ready for review in May 2022 for Class IIb and III devices, and May 2023 for Class IIa devices.
It may feel like there is plenty of time to prepare and no need to start yet, but it's important to recognize the amount of work involved in implementing this new process for an entire portfolio. Identifying database limitations, finalizing a process and...
2021-05-2044 min
Making MedTech Happen with RQM+Live! #34 — Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.
We all have the same goals when submitting technical documentation to the notified body for review:
Minimize questions
Minimize deficiencies
Achieve certification
There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.
We'll...
2021-05-0655 min
Making MedTech Happen with RQM+Live! #33 — Types of EU MDR Clinical Evidence Gaps and Best Practice SolutionsThis is the audio-only version of RQM+ Live! #33, originally recorded April 22, 2021.
"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:
What types of clinical evidence gaps are notified bodies citing?
What are some solutions to enable keeping your devices on the market?
What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified...
2021-04-2351 min
Making MedTech Happen with RQM+Live! #32 — What if I'm not ready for EU MDR on May 26, 2021?This is the audio-only version of RQM+ Live! #32, originally recorded April 8, 2021.
The MDR Date of Application is just around the corner, and there is no indication of another delay coming. If some or all of your products won't be ready in time, you may be starting to panic. In this show we'll start by debunking the bad ideas that we've heard. Here are some examples:
No, you should not reclassify all of your Class I devices to Class Ir to gain extra time; classifications need to be done correctly
No, you should not start calling your...
2021-04-0849 minMaking MedTech Happen with RQM+Live! #31 — Biological Equivalence DemystifiedThis is the audio-only version of RQM+ Live! #31, originally recorded March 25, 2021.
In connection with biological equivalence, the MDR states, “the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.”
The intent behind using an equivalence strategy in the EU is to leverage the clinical data from the equivalent device via an assessment of risks arising out of any potential similarities or differences that may have an impact of the...
2021-03-2652 min
Making MedTech Happen with RQM+Live! #30 — IVD Intended Purpose Statements – Defining for SuccessThis is the audio-only version of RQM+ Live! #30, originally recorded March 11, 2021.
The first and arguably most critical step in the IVDR implementation process is determining if you have a compliant intended purpose statement. This has proven to be challenging, even for legacy devices, and has already resulted in notified body findings for manufacturers who are getting a head start over others in the industry.
It's important the intended purpose statement be compliant while also serving the business strategy. Considerations are:
Does the statement meet the definition of an IVD device under IVDR?
Is the...
2021-03-1136 minMaking MedTech Happen with RQM+Live! #29 — The surprising true cost of submitting non-compliant technical documentation to notified bodiesThis is the audio-only version of DEVICE LOVE Live! #29, originally recorded February 25, 2021.
There has been plenty of discussion regarding what "good enough" means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “grandfathering” for legacy devices, which means that in some cases significant technical documentation remediation may be required (with similarly significant associated costs). There is also a more explicit emphasis on PMS, PMCF, and continual updates of rela...
2021-02-2549 min
Making MedTech Happen with RQM+Live! #28 — Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDRThis is the audio-only version of DEVICE LOVE Live! #28, originally recorded February 11, 2021.
The MDR and IVDR have significantly increased requirements for clinical, regulatory, and post-market surveillance documentation. To make it even more challenging, there are overlapping requirements resulting in the need for consistent information across a variety of plans and reports. The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task, however, it's essential to ensure consistent information across all plans and reports: CEP/PEP, CER/PER, risk management file, labeling, PSUR, PMCF/PMPF, and SSCP/SSP.
Our...
2021-02-1256 min