Module 16 2022

9/2/2022

Lecture 6: Post Market Clinical Follow-Up

Presented by:

Adrian Keene, Senior Director, Global Biological Safety and Validation and EMEA Consulting Services

Date:

September 2022

© NAMSA 2021

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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

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