Course Area
Availability
Available for 90 days after enrollment
Approximate Course Run Time
1 hour
Continuing Education Units
0.1
Course Fee
No charge
E-learning content is available on demand
Course Details
Overview
This webinar will provide manufacturers with an understanding of BSI expectation in relation to PSURs and provide an overview of the recent guidance related to PSURs (MDCG 2022-21). Manufacturers will also learn how and when to submit PSURs to BSI using the BSI Electronic Client Portal and also when they are required to update and provide SSCPs alongside the PSUR.
Key takeaways and learning objectives
What will participants gain?
- An understanding of BSI expectations in relation to PSUR.
- An overview of MDCG 2022-25.
- How to correctly submit PSURs to the notified body.
- When to submit SSCPs alongside PSURs.
Presenter information
Speaker - Richard Holborow, Head of Clinical Compliance, BSI
Speaker - Maddalena Pinsi, Regulatory, BSI
