Is your team trained on how to prepare a post-market surveillance summary report to comply with SOR/2020-262 (deadline is December 23, 2021).
Register for the live Post-Market Surveillance Summary Report Webinar
We hosted a live webinar on Thursday, December 23, 2021 @ Noon EST. The post-market surveillance summary report webinar was almost exactly one hour in duration plus questions and answers. The recording is available for download along with the native slide deck. In this webinar you will learn the following:
- Overview of the new Canadian Regulation (SOR/2020-262)
- How to prevent missing future regulatory changes from Health Canada
- How to prepare a quality system plan for implementation of the new regulation
- How to prepare a post-market surveillance summary report
- How to document updates to your risk management file–including the benefit/risk analysis
- When you need to notify the Minister of changes to the benefit/risk analysis conclusions
Purchase the Post-Market Surveillance Summary Report Webinar Recording & Native Slidedeck
You may also be interested in our Post-market Surveillance Procedure (SYS-019). The procedure has been updated to include the summary report requirements for the EU and Health Canada.
About the Author
Robert Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.