Module 16 2024

21/10/2024

Lecture 7: Post Market Clinical Follow-Up

Adrian Keene, Associate Vice President, Global Biological Safety and Global Regulatory Consulting Services Date: October 2024

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Post Market Surveillance: Requirements and PMCF Strategies

• Agenda - Background and context - Article 120 Requirements - Guidance to consider - PMCF strategies

- Legacy device PMCF scenarios - Notified Body experience to date - Conclusions

© NAMSA 2023 | 2

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