Episode Details


This is the audio from RQM+ Live! #49, originally recorded 24 February, 2022.

PSURs (Periodic Safety Update Reports) are required to be ready for notified body review in May of 2022 for medical devices or May of 2023 for IVDs. Implementing this new PSUR process for an entire portfolio by the deadline and then sustaining the effort is a monumental lift for most manufacturers. Identifying database limitations, finalizing a process and template, and finding efficiencies are keys to creating a smooth and sustainable process.

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.

Topics include:

  • Methods of satisfying requirements,
  • Implementation tips to consider across the lifecycle of your device,
  • Response strategy to common notified body deficiencies
  • Development of a sustainable process for PSUR generation and yearly updates
  • Alignment of PSUR and CER processes to avoid data inconsistencies and duplications in effort
  • Best practices that improve efficiency

Panelists include subject-matter and former notified body experts:

  • Amie Smirthwaite, BEng, Ph.D.  Senior Vice President, Intelligence & Innovation
  • Carlos Galamba, MSc  Vice President of IVD Intelligence & Innovation
  • Celeste Maksim, Ph.D., RAC  Chief of Staff
  • Jan Kloiber – Senior Principal Specialist
  • Daniel Colón – Senior Engineer

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