Episode Details

This 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 template, and finding efficiencies will be keys to creating a smooth process. Similarly, Health Canada's new requirements for post-market summary reports and issue-related analyses for Class II, III, and IV medical devices come into force December 2021. Starting implementation of both the PSUR and HC Summary Report requirements now will enable time to establish an effective and efficient process that doesn't drain your resources.
 
We're supporting clients with implementation and have received many questions. Here are some of the questions that we plan to discuss in this show:
  • What is the best approach to implementing the PMS plan?
  • What are best practices that improve efficiency?
  • How do we deal with the clinical literature being updated if its off-cycle from the CER?
  • Is it ok for the PSUR to just reference the literature in the CER?
  • How many years of data do we need to include?
  • What do we do if our databases don't support implementation of the PMS plan?  For example, if we only keep 2 years of sales data.
  • What are the best methods of statistical trending for vigilance reporting?
  • How do we align Health Canada and MDR requirements and expectations?  What are ways to simplify the report to meet both requirements?
Please bring your questions for our SME's and former notified body leaders to answer LIVE!
Panelists:

    • Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Service
    • Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
    • Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
    • Brian Hockett - Principal Engineer

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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