What is the webinar about?

An opportunity for BSI to share best practices on compiling and submitting Periodic Safety Update Report (PSURs) for Notified Body evaluation. 

Topics to cover will include:

  • The role of MDCG 2022-21 guidance on PSUR for manufacturers
  • providing justifications and analysis
  • the data collection period
  • stratification of data
  • Change notification via the PSUR

What will participants gain?

  • An understanding of how to ensure the PSUR meets requirements
  • Awareness of PMS/PMCF requirements which if not adequately addressed in the PSUR may result in Notified Body action
  • Tips for a smooth submission and evaluation of the PSUR by BSI.

Who should attend?

This insightful webinar will be beneficial for those with medical device Post-market Surveillance responsibilities under EU MDR. Additionally, medical device manufacturers wanting more information about PSURs and consultants on the EU MDR.

Speakers

 
Jenifer
Hannon
Post Market Surveillance Regulatory Lead
Andrew
Butler
Technical Team Manager - Orthopaedics and Dental
Susan
Partridge
Clinical Regulatory Lead

To find out more about Medical Devices and patient safety, visit our dedicated Medical Devices webpage and follow us on LinkedIn at BSI Medical Devices.

Email: medicaldevices@bsigroup.com

Phone: +44 3450809000

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