Processes, templates, efficiencies, and other best practices for all things PSURs.
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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:
Please bring your questions for our SME's and former notified body leaders to answer LIVE!