Shows
RAQA TodayQMSR, AI Reviewers and the Value of a Good FDA and Internal AuditIn this episode Michelle and Adam Foresman from Ryden Solutions do a deep dive into right-sizing quality systems, lean regulatory practices, and the evolving landscape of AI-driven compliance tools in medtech. They reflect on personal pain points that sparked their ventures, swap audit war stories, and share insights into regulatory shifts like QMSR, MDR, and de-harmonization trends.
Highlights:
- The hidden costs of over-documentation and duplicated audits
- How AI can proactively identify compliance gaps — even across languages
- The future of audits: less paper, more floor time, and higher impact
- Why global harmonization is unraveling, and what that me...2025-06-2736 min
RAQA TodayWhat You Need to Know About FDA Breakthrough DevicesThe FDA Breakthrough Device Program offers a expedited path to market for medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It allows for prioritized review and enhanced communication with the FDA to help bring innovative devices to market more quickly, but it's not for everyone.
In this podcast, Michelle reviews the specifics of the program - the benefits, the requirements, the challenges - and talks about how you can decide if the program is right for you and your device.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https...2025-06-1623 min
132 Problems: Revisiting Mormon Polygamy161: Brigham's Transfiguration & Joseph's Polygamy: Two Dubious NarrativesPlease consider supporting this podcast: Venmo: @Michelle-Stone-24Patreon.com/132problemsJohn Dehlin brings up very good points about the problems with the dubious story of the transfiguration of Brigham Young. Hopefully he and his audience can see that the story of Joseph Smith's polygamy suffers from the exact same problems. This is a fun one.Links:Episode 148 on James Whitehead and W.W. Blair's Journal: https://youtu.be/VvOjyZhHPVs Episode on Malissa Lott: https://youtu.be/dGwxwe3mjg4 Mormon Stories Episode: https://www.youtube.com/watch?v=uVdOZzgeyG0Alzina L. Willes RS talk https://www.familysearch.org/en/tree/person...2025-03-162h 08
Medical Device made Easy PodcastFDA: Advantage of the Breakthrough Device Program
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Devi...2025-02-2700 minMedical Device made Easy PodcastFDA: Advantage of the Breakthrough Device Program
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Devi...2025-02-2700 min132 Problems: Revisiting Mormon Polygamy155: The Lott Family Bible - Proof of Joseph's Polygamy?Please consider supporting this podcast: Venmo: @Michelle-Stone-24Patreon.com/132problemsLinks:Lott Family Bible: https://catalog.churchofjesuschrist.org/assets/7226d36f-b3a5-4c0e-9d0c-33d87d46ffb4/0/3Joseph F. Smith Reminiscence (re Cornelius Lott): https://catalog.churchofjesuschrist.org/assets/dcbc02ae-b054-44d8-9381-de93c8cb9a37/0/20 Like a Fiery Meteor (Biography of Joseph F. Smith: Paperback: https://amzn.to/4hDXHOxKindle: https://amzn.to/3PWMcFZ Nauvoo Sealings, Adoptions and Anointings: https://archive.org/details/nauvoo-sealings-adoptions-and-anointings/page/188/mode/2up?q=corneliusLetter from Rebecca Fausett’s Father: https://www.familysearch.org/tree/person/memories/KWV9-MFC Sealing Letter re...2025-02-021h 51
RAQA TodayBiocompatibility for MedTech ProfessionalsEverything you need to know about biocompatibility - in one podcast.
From a webinar hosted by MedTech Leading Voice and featuring Michelle and Marina Daineko from Intrinsic Medical Group.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa2024-12-0652 min
RAQA TodayCE Certification vs FDA Submission Strategy: Which is Right for You?Which market is best for your product - the EU or the US?
The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.
Michelle leads off with a review of FDA strategies and pathways.
15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies.
27:15 - Nika Mendelev explains whether you really need to choose one or the other.
32:10 - the Q+A session begins.
Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY2024-10-0149 min
Flicker EffectBeetlejuice Beetlejuice, Dragon Con 2024 Follow-UpDave and Michelle discuss last weekend's DragonCon and review Beetlejuice Beetlejuice. Learn more about your ad choices. Visit megaphone.fm/adchoices2024-09-101h 15
Flicker EffectSan Diego Comic-Con 2024 News RoundupDave and Michelle chat live during the Marvel Hall H panel to discuss all the big news from this year's SDCC. Learn more about your ad choices. Visit megaphone.fm/adchoices2024-08-011h 02
Life Sciences - In FocusLife Sciences - In Focus Ep 03 - Michelle Lott, Lean RAQAIn this Life Sciences In-Focus podcast episode, host Karen Tkaczyk sat down with Michelle Lott, the founder and principal of Lean RAQA, to discuss the intricate world of regulatory affairs within the life sciences sector. This conversation not only shed light on Michelle's unique journey into the field but also explored the challenges and nuances of navigating regulatory pathways in the United States and Europe.
About the Host
Karen Tkaczyk
Director of Sales for the Vistatec Life Sciences Division. Karen is an accomplished chemist and translator with extensive experience in the drug, medical d...2024-04-3023 min
Project MedtechEpisode 179 | Michelle Lott, Principal and Founder at LeanRAQA | FDA and MDR UpdatesIn this episode, Michelle Lott at LeanRAQA and Duane Mancini discuss the QMSR, FDA e-start program, 513g vs. presubmission meeting, MDR update and so much more.2024-04-2235 min
Flicker EffectGhostbusters: Frozen Empire ReviewDavid, Bobby, and Michelle review Ghostbusters: Frozen Empire. Learn more about your ad choices. Visit megaphone.fm/adchoices2024-04-111h 08
More Than Fine193. The Games Abusers Play | Tricia Lott Williford & Jana RichardsonFor many coming to terms with an abusive relationship, there is often a stage in which you wonder, "How did I get here in the first place?" Michelle discusses the early stages of the abusive dynamic with survivor Tricia Lott Williford and therapist Jana Richardson MA LPC EMDR. They delve into the grooming tactics many abusers use to manipulate and deceive their victims, and highlight what you can do to avoid being drawn in by an abuser again. Purchase You are Safe Now: A Survivor's Guide to Listening to Your Gut, Healing from Abuse, & Living in Freedom2024-04-1053 min
Flicker EffectOscars 2024David, Bobby, and Michelle discuss this years Oscars. Learn more about your ad choices. Visit megaphone.fm/adchoices2024-03-131h 12
Flicker EffectDune Part 2 ReviewDave, Bobby, and Michelle discuss Dune Part 2. Learn more about your ad choices. Visit megaphone.fm/adchoices2024-03-111h 08
The Med-Tech Talent LabMed-Tech Startups-When to hire your first Reg Affairs & Quality FTEThe Med-Tech Talent Lab kicks off its 3rd season with a guest who is no stranger to the show! Mitch Robbins sat down with Michelle Lott, Founder of Lean RA/QA, a consulting firm helping Med-Tech startups across the US with all things Regulatory & Quality to discuss when exactly is the right time to hire your first full-time RA/QA employee.During the episode Mitch & Michelle discussed:-Indicators for when it's time to hire a full time RA/QA professional-How fractional help makes the most sense early-The scope of...2024-01-1925 min
RAQA TodayMedical Devices, Cloud Computing and Cybersecurity with Randy HortonAs medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA plans to do to ensure the safety of connected and AI-driven devices.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa2023-11-2927 min132 Problems: Revisiting Mormon Polygamy71: One "Polygamy Denier's" Response to Bill Reel, RFM and Brian Hales | 132 ProblemsPlease consider supporting this podcast:
Venmo: @Michelle-Stone-24
https://www.patreon.com/132Problems
Multiple podcasts hit pretty hard last week against people who have come to believe that polygamy did not originate with Joseph Smith. As has always been the case, although they agree on almost nothing else, both those who hate Joseph Smith and think the worst of him, and those who claim to love him and believe they are following in his name, agree on this one central point -- that polygamy started with Joseph Smith.
Both...2023-11-172h 39
Flicker EffectThe Fall of the House of UsherDavid, Bobby, and Michelle discuss The Fall of the House of Usher. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-11-021h 28
Let's Combinate - Drugs + Devices106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle LottOn this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!
If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and...2023-10-2433 min
Flicker EffectAhsoka Ep 8 ReviewDave, Bobby, and Michelle discuss the finale to season 1 of Ahsoka. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-10-111h 18
Flicker EffectAhsoka Ep 6 ReviewDave, Bobby, and Michelle discuss Ahsoka episode 6. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-09-271h 14
Flicker EffectAhsoka Ep 1 & 2Dave, Bobby, and Michelle discuss the first 2 episodes of Ahsoka. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-09-111h 13
Flicker EffectHow To DragonConThis week, Dave and Michelle discuss DragonCon, the annual sci-fi convention held in Atlanta, GA. After a few years of experience, they share their tips for attending the pop culture extravaganza!Official Website: https://www.dragoncon.org/Dragon Con Rooms Group: https://www.facebook.com/groups/dragonconroomsgroup Learn more about your ad choices. Visit megaphone.fm/adchoices2023-08-161h 10
Flicker EffectBarbenheimer ReviewAfter a bit of a delay due to San Diego Comic-Con, we have finally seen both Barbie and Oppenheimer and it's time to discuss! Dave, Bobby, and Michelle review the films spoiler-free, and also talk Barbie spoilers at the end of the episode.YouTube Video: https://youtu.be/RcvLeTTvH7c Learn more about your ad choices. Visit megaphone.fm/adchoices2023-08-091h 23
Flicker EffectMission: Impossible – Dead Reckoning Part One ReviewDave, Bobby, and Michelle discuss Mission: Impossible - Dead Reckoning Part One. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-08-031h 01
Atlanta REALTORS® RundownRaised by YPN with Guest Speaker(s) Amanda Lott and Michelle DohertyJoin your host, Kate Wright, as she engages in a fascinating conversation with two incredible guests, Amanda Lott and Michelle Doherty. Together, they unravel the numerous ways the Young Professionals Network (YPN) has opened doors to remarkable leadership opportunities within their respective associations.
Prepare to be inspired by diverse voices from across the country, as Amanda and Michelle share their personal journeys and how YPN has played a pivotal role in shaping their paths. Discover the transformative power of YPN and its ability to empower young professionals, enabling them to flourish and take on leadership roles that...2023-07-2528 min
Flicker EffectIndiana Jones and the Dial of Destiny ReviewDave, Bobby, and Michelle review Indiana Jones and the Dial of Destiny. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-07-131h 19
Flicker EffectSuperman Casting and SDCC NewsDave, Bobby, and Michelle discuss some Superman: Legacy casting news, the lack of big studio presence at the upcoming San Diego Comic-Con, The Flash, Elemental, and more. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-07-131h 30
Flicker EffectThe Flash Non-Spoiler Review, Indiana Jones 5 ReactionsDave and Michelle share their thoughts on The Flash and discuss the first reactions to Indiana Jones and the Dial of Destiny. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-06-2340 min
Flicker EffectShould Movies Tell Us If They Are A Part One?Dave, Bobby, and Michelle discuss a question: Should movies tell if they are actually part 1 of 2 movies (or more)? Or do we like the surprise? Learn more about your ad choices. Visit megaphone.fm/adchoices2023-05-2841 min
Let's Combinate - Drugs + Devices077 - 8 Databases and How To Use Them with Michelle LottOn this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them!
If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Dev...2023-03-2222 min
Let's Combinate - Drugs + Devices069 - EU MDR Extension with Michelle LottOn this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry.
If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and...2023-01-2517 min
Flicker EffectTop 10 Films of 2022David, Bobby, Jascha, and Michelle countdown their top 10 films of 2022. Learn more about your ad choices. Visit megaphone.fm/adchoices2023-01-212h 00
Flicker EffectGlass Onion and BabylonDavid and Michelle discuss Glass Onion and Babylon. Timestamps: Glass Onion Review ~00:03:20 Babylon Review ~00:19:20 Babylon SPOILERS ~00:38:30 Learn more about your ad choices. Visit megaphone.fm/adchoices2022-12-301h 12
Flicker EffectAvatar: The Way of Water ReviewAfter a 13 year wait, the time has finally come for a sequel to Avatar. In this episode, David, Bobby, and Michelle discuss Avatar: The Way of Water. Learn more about your ad choices. Visit megaphone.fm/adchoices2022-12-271h 32
RAQA TodayTrends in FDA Initiatives and the Impact on Orthopedic DevicesOrthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new office to manage orthopedic devices - the Office of Science and Engineering Laboratories (OSEL) - and ensure their safety and efficacy. OSEL was created to accelerate patient access to innovative devices, as was the Orthopedic Devices Program. In this podcast, Michelle walks through the important work that OSEL is doing and the regulatory specifics you need to know when preparing the submission for your orthopedic device.2022-11-1538 min
RAQA TodayFree FDA Communications with the FDA? What you Need to KnowThere's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through the commercialization process.2022-11-0850 min
RAQA TodayCrash Course in FDA SubmissionsSo - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub?
If you've answered NO to any of these, then listen in as Michelle explains what you need to do to help your product move smoothly through the submission process and on to premarket approval.2022-08-3125 min
RAQA TodayBreakthrough, de novo, or PMA? FDA Submission Pathways for Novel DevicesYou've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar?
Breathe - and listen in as Michelle walks you through the options.2022-08-0947 min
Flicker EffectNope Spoiler ReviewJordan Peele's Nope is now in theaters and David, Bobby, and Michelle sit down to discuss the film, spoilers included! Learn more about your ad choices. Visit megaphone.fm/adchoices2022-07-3142 min
Flicker EffectThor: Love and Thunder Spoiler ReviewAfter a bit of a delay (vacation, Covid), we've finally gotten around to talking about Thor: Love and Thunder. David, Bobby, and Michelle discuss the film, spoilers included! Learn more about your ad choices. Visit megaphone.fm/adchoices2022-07-231h 05
Global Medical Device Podcast powered by Greenlight GuruChallenges for Regulatory Submission: EU vs. USWhat are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, aud...2022-05-0640 min
Let's Combinate - Drugs + Devices031 - "The Five Stages Of Regulatory Grief" with Michelle LottOn this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss:
- Her background starting at a manufacturing site and moving into QA and RA
- Being Outspoken and Honest
- What she's observed between large and small organizations
- Her Experience being an industry rep on the FDA Device GMP Advisory Committee
- Regulations vs. Guidance's and how they come about
- The 5 stages of regulatory grief
- QMSR Harmonization
- Audit Preparation
...2022-05-041h 19
RAQA TodayThe Aftermath of MDR - Part IIt's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.2021-12-1615 min
Project MedtechEpisode 71 | Michelle Lott: Principal and Founder at LeanRAQA | Regulatory Strategy and its Place in a Medtech Startup Business Plan
In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more.
Michelle Lott LinkedIn
LeanRAQA Website
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website
2021-11-2948 min
A Lott Of Help with James Lott JrYou Can't Make This S**t Up with Abuse Survivor/Author Michelle MaysMichelle Mays was born into an abusive family in the Midwest. As she and her siblings cling to survival, the balance of family ties is weighed against alcoholism, drug abuse, abandonment, and despair. Hope dawns in the form of foster care, only to be deferred by multiple placements and a system not equipped to support the children it's meant to protect.Through powerful vignettes of a life disjointed, Mays's story is a journey of hope that is echoed in the experiences of thousands of children in the court and foster care systems today.Dumpster Doll is...2021-10-2643 min
Flicker EffectVenom: Let There Be CarnageThis week on the podcast: David, Bobby, and Michelle discuss Venom: Let There Be Carnage, some predictions for No Time To Die and the future of Bond, the Johansson/Disney settlement, and more. Learn more about your ad choices. Visit megaphone.fm/adchoices2021-10-051h 09
Flicker EffectShang-Chi Spoiler ReviewWe're back! We're talking about Dave and Michelle's adventures at DragonCon and of course Shang-Chi! Learn more about your ad choices. Visit megaphone.fm/adchoices2021-09-211h 14
Flicker EffectThe ProtégéDavid, Bobby, Jascha, and Michelle discuss The Protégé, The Eternals trailer, What If?, and more. Learn more about your ad choices. Visit megaphone.fm/adchoices2021-09-201h 12
Flicker EffectThe Suicide SquadDavid, Jascha, and Michelle discuss James Gunn's 'The Suicide Squad' and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2021-09-1955 min
Flicker EffectJungle CruiseDavid, Bobby, Jascha, and Michelle discuss Jungle Cruise, Old, The Forever Purge, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2021-08-071h 26
Flicker EffectBlack Widow Spoiler ReviewDavid, Bobby, Jascha, and Michelle share their spoiler review of Marvel's latest film, Black Widow. Learn more about your ad choices. Visit megaphone.fm/adchoices2021-07-1547 minMedical Device made Easy PodcastFDA: Is the Emergency Use Authorization worth it? (EUA)
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA.
This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create some headache.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA...2021-05-1100 minMedical Device made Easy PodcastFDA: Is the Emergency Use Authorization worth it? (EUA)
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA.
This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create some headache.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA...2021-05-1100 min
RAQA TodayFDA Submission Pathways with EIT Health AlumniDetermining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.2021-04-0132 minRAQA TodayAll You Ever Wanted to Know About Risk Management with Edwin BillsNo matter the risk management question, Edwin Bills will likely have the answer. He's been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that, maybe more than once.
Ed sat down with Michelle to talk about ISO 24971, MDR and the risk of radiation exposure in a sun-filled hospital room.2021-03-1244 minRAQA TodayRegulatory and Reimbursement - Similar but DifferentAre regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?
Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas actually may overlap in a variety of medical device scenarios.2021-03-0439 minRAQA TodayEntrepreneurial Roundtable with Elena KyriaIn this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk about the benefits and challenges of running your own business.
You can hear the entire discussion at http://www.elemed.eu/mentoring2021-02-1117 minMedical Device made Easy PodcastWhat is the QA RA Mindset with Michelle Lott
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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on...2021-02-0900 minMedical Device made Easy PodcastWhat is the QA RA Mindset with Michelle Lott
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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on...2021-02-0900 min
Medical Device made Easy PodcastWhat is the QA RA Mindset with Michelle LottIf you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast.2021-02-0936 min
RAQA TodayAre You Ready for MDR - Part IMichelle was invited to speak to the Southern California chapter of Opthalmic World Leaders (OWL) and familarize them with the basics of the approaching MDR transition.2021-01-2925 min
Career Diaries by ElemedSPECIAL EPISODE | The story of Elemed | Elena Kyria, CEO of Elemed and Michelle Lott, Founder of Lean RAQA SystemsKey takeaways:The secrets and success of a WOMEN-LED businessHow Elemed’s Mentoring Academy was a GAME-CHANGERHow to use your passions and skillset to SUCCEEDElemed’s EXCITING story and why you should start your own businessAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be emotio...2021-01-2933 minRAQA TodayRegulatory Requirements and the "Simple" Surgical MaskYou have a raw material supplier. You have a marketing strategy. You have a sales funnel. But what you don't have is a clear understanding of the regulatory requirements for this new surgical mask you're making.
Now what? Do you even know where to start?
Michelle sits down with a client facing this dilemma and walks her through the regulatory process and requirements for a "simple" surgical mask. (Hint - there's no such thing).2021-01-2211 min
Flicker EffectWonder Woman 1984 Spoiler ReviewDavid, Bobby, Jascha, and Michelle dig deep into Wonder Woman 1984, spoilers and all. Learn more about your ad choices. Visit megaphone.fm/adchoices2021-01-141h 38RAQA TodayRAQA Today Becomes leanRAQA Today: What's Next?Mitch Robbins is moving on, and Michelle Lott of lean RAQA will be taking over the podcast! Mitch and Michelle chat about transitioning the podcast, what's ahead for the Anthony Michael Group, and what the leanRAQA team has in store for 2021.2021-01-1326 min
Flicker EffectWonder Woman 1984, SoulThis week on the show, David and Michelle discuss Wonder Woman 1984, Soul, A Teacher, The Flight Attendant, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-12-311h 07
Scary ThoughtsScary Thoughts #82 - “Is this how you thought it would all end?” with Michelle Tea, Meg Elison and Lawrence English Writer Michelle Tea, writer Meg Elison, and composer Lawrence English join us for a trio of COVID-19-era conversations. We ask them each, “Is this how you thought it would all end?” All three guests have great perspectives on the apocalyptic vibrations affecting us all, but are any of us truly ready for the end? 2020-10-091h 02
Flicker EffectProject Power, SputnikThis week we're discussing Netflix's "Project Power", "Sputnik", and our top 5 sequels that are better than the original! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-08-181h 47
Flicker EffectAn American Pickle, The RentalThis week we discuss An American Pickle, The Rental, She Dies Tomorrow and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-08-111h 25
Flicker EffectTop 5 Sci-Fi Movies in SpaceThis week: We countdown our top 5 sci-fi movies in space while also discussing "The Umbrella Academy" Season 2, "Yes, God Yes", and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-08-111h 50
Flicker EffectNews - Comic-Con@Home, 2020 Emmy NominationsDavid and Bobby discuss the latest entertainment news including this past weekend's Comic-Con@Home, the 2020 Emmy nominations, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-08-0448 min
Career Diaries by ElemedThe benefits & challenges of being a RA/QA consultant | Michelle Lott, Founder of Lean RAQA SystemsKey takeaways:Learn the BENEFITS of being self-employed from an experienced consultantWhat is BRAND CONSISTENCY and why you need to be aware of thisHow to become an independent SUCCESS and start your own businessHow to GROW in the RAQA industryAbout Michelle:Michelle Lott is founder and principal of Lean RAQA Systems (leanraqa.com) where she has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services and grief counseling – because dealing with regulators can be em...2020-08-0353 min
Flicker EffectHamilton Film Review, The Old Guard, GreyhoundThis week we discuss the Hamilton Film, Tom Hank's Greyhound, Netflix's The Old Guard, and more! Plus, we take some time to countdown our Top 5 80's Action films! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-07-141h 49
Flicker EffectMichael Keaton Back as Batman, AMC Theaters Set to ReopenIn this latest edition of Flicker Effect News, David and Bobby discuss talk of Michael Keaton's return to Batman, AMC Theaters and their plans to reopen, the Playstation 5 reveal, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-06-251h 02
Flicker EffectWhat We're Watching During the QuarantineThis week we talk about everything we've been watching lately during our self quarantine. We discuss Portrait of a Lady on Fire, Emma, Little Fires Everywhere, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-04-071h 24
Flicker EffectHigh Fidelity, Birds of PreyDavid, Bobby, Jascha, and Michelle discuss Hulu's High Fidelity series, Birds of Prey, the new Batsuit, and much more. Learn more about your ad choices. Visit megaphone.fm/adchoices2020-02-281h 13
Flicker EffectThese Aren't the Scripts You're Looking ForThe news is back, and this week the Obi-Wan series loses a writer, Disney is making more live-action remakes, and Tarantino is making a TV show? Plus, Jascha gives us his WTF and Top 10 list for 2019! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-01-281h 11
The Mind Games Podcast with Hailey and Ronnie LottMichelle Pellizzon of Holisticism on Mental Wellness for AllHolistic medicine is changing lives - permanently. In this episode Michelle Pellizzon, the Founder & CEO of Holisticism, discusses life-changing introduction to holistic wellness, and reveals how mental health and physical health are related. She also talks about her own struggle with epilepsy, and what that brought her to not only be healed holistically - but open a company to help others to do the same.2020-01-2100 min
Flicker EffectTop 10 Films of 2019It's our first episode of the new year, and what better way to celebrate than by taking a look back at the movies of 2019. That's right, it's our Top 10 list for 2019! Let's go!! Learn more about your ad choices. Visit megaphone.fm/adchoices2020-01-142h 23Medical Device made Easy PodcastHow to register your Medical Device through 510k with Michelle Lott
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510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.
We will discuss the different types that are existing:
TraditionalAbbreviatedSpecial
We will also discuss the way to use standards to confirm that your product conforms to...2020-01-1300 minMedical Device made Easy PodcastHow to register your Medical Device through 510k with Michelle Lott
Subscribe
510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.
We will discuss the different types that are existing:
TraditionalAbbreviatedSpecial
We will also discuss the way to use standards to confirm that your product conforms to...2020-01-1300 min
Flicker EffectStar Wars: The Rise of SkywalkerThe time has come. The end of a saga has arrived. In this week's episode we sit down to discuss Star Wars: The Rise of Skywalker. Our spoiler-free and spoiler-filled (with plenty of warning) are both given, so hit play to hear it all! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-12-271h 42
Flicker EffectJumanji Still Has LivesJumanji: The Next Level looks to repeat the success of the previous film, and it's off to a great start. Meanwhile, Star Wars is around the corner, and it's on all of our minds. Join us for a Star Wars heavy discussion and get excited with us! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-12-171h 18
Flicker EffectMidway Soars, While Doctor Sleep SnoresThis week we discuss the slow box office weekend, but more importantly, how David and Michelle saw movies! They've got thoughts on Jojo Rabbit, Parasite, Doctor Sleep, and more! Time to start the show! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-11-121h 05
Flicker EffectTerminator Won't Be Back?Well, we're covering Terminator: Dark Fate, which sounds ironic in retrospect. Plus, David and Michelle bite into the new Apple TV+ show - Morning Show. All that and more in this week's episode! Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices2019-11-051h 11
Flicker EffectStar Wars Tickets, Riddler CastingThis week, David and Michelle discuss the latest news including the casting of the Riddler, the Star Wars: The Rise of Skywalker ticket sale, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-10-2245 min
Flicker EffectJoker: Spoiler ReviewNow it's time for the rest of the crew to talk about Joker! In this episode, Kevin Fuentes joins David, Jascha, and Michelle to have a spoiler-filled discussion of the latest DC film. Learn more about your ad choices. Visit megaphone.fm/adchoices2019-10-101h 16Medical Device made Easy PodcastRegister your Medical Device in the US with Michelle Lott (FDA)
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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the...2019-09-3000 minMedical Device made Easy PodcastRegister your Medical Device in the US with Michelle Lott (FDA)
Subscribe
The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the...2019-09-3000 min
Flicker EffectD23 2019David, Bobby, and Michelle discuss all the big news out of D23, including the Disney+ announcements, the latest from the MCU, The Mandalorian, and more! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-09-071h 32
Flicker EffectBonus Ep - Spider-Man Out Of The MCU?In this special bonus episode, David, Bobby, and Michelle discuss the breaking news that Spider-Man may be out of future MCU films. Learn more about your ad choices. Visit megaphone.fm/adchoices2019-09-0742 min
Gravity Lab Radio#106 Michelle Nirumandrad/Captured SkySkydiving is considered an artform by most. Michelle takes it to the next level and makes art while skydiving. Michelle is the talented mind behind Captured Sky, where she releases paint on canvas in freefall. Michelle and Captured Sky were recently featured by Ripley's Believe it or Not. This is a guest we have been trying to line up for awhile and can't wait to share Michelle's story and learn about her concept and inspiration.
You can follow Michelle and Captured Sky on:
Facebook: @michelle.nirumandrad @capturedsky
Instagram: @capturedskyart
Gravit...2019-08-221h 59
Flicker EffectHobbs & ShawThis week , Michelle and David are going back to Cali as they revisit Once Upon a Time in Hollywood, plus Bobby talks about Hobbs and Shaw and The Farewell. Also, someone else has checked out Star Wars Galaxy's Edge. So go ahead and hit play to find out who. Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices2019-08-061h 08
Flicker EffectMen in Black: InternationalMIB: International is out in theaters, and we're talking about it. Plus, did The Satanic Temple gain new fans in David and Michelle after watching the indie documentary 'Hail Satan?' Find out in this week's episode! Music: “Whistle” by BenJamin Banger, on Instagram @BenJaminBanger and at https://www.benbanger.com Learn more about your ad choices. Visit megaphone.fm/adchoices2019-06-181h 15
Flicker EffectGodzilla: King of the MonstersThis week, David and Michelle discuss John Wick: Chapter 3, Game of Thrones: The Last Watch, Godzilla: King of the Monsters, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-06-061h 32
Flicker EffectEp 282 - Lego Movie 2, Super Bowl, and HamiltonIn our latest episode, Jascha shares his Super Bowl experience, David and Michelle discuss The Lego Movie 2 and their first experience seeing Hamilton, and much more! Learn more about your ad choices. Visit megaphone.fm/adchoices2019-02-121h 10
Flicker EffectEp 274 - Ralph Breaks the Internet, Creed IIDavid, Bobby, and Michelle sit down to discuss Ralph Breaks the Internet, Creed II, the new Lion King trailer, and of course a little more Fantastic Breasts: The Crimes of Grindelwald talk has to happen. Learn more about your ad choices. Visit megaphone.fm/adchoices2018-11-301h 17