Description

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 part 2.

It's obvious that industry is very concerned with the upcoming MDR and IVDR deadlines related to PSURs and unfortunately, there is still a lot of uncertainty and confusion. We're here to help! In part 2 of this discussion, we'll begin with audience questions we didn't get to last time, including:

• Do we need the IMDRF coding only for reportable cases or for all complaints coming in and include in the PSUR?
• Do you have any implementation tips to consider across the device lifecycle? What should we think about when building our maintenance program?
• If we have not sold anything commercially, but we do have a system out for clinical study use, do we need to create a PSUR?
• For legacy devices that are no longer sold, therefore not intended to be MDR certified, is the intent that the PSUR/PMSR just be available upon request or does it need to be proactively submitted to the last Notified Body that certified the device?
• Will the PSUR guidance define the length of the reporting period?
• What type, method and level of trending is expected in the PSUR?
• What data should you use for similar devices - literature, registries, any other?

Panelists:

• Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
• Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
• Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
• Celeste Maksim, Ph.D., RAC – Chief of Staff

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About RQM+

RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. We deliver transformative solutions by providing unrivaled collective expertise fueled by our passion for client success. Our team is collaborative, laser-focused on client needs, and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.