RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+_Live_53_Recorded

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?
Please bring all of your PSUR-related questions for our SME's and join the discussion.

  • 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

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer