Module 15 Presentations

10/04/2024

Lecture 6: The relationship between clinical evaluation and post-market surveillance (PMS)

Paul Risborough, 02-APR-2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Agenda

• Re-cap of the clinical evaluation process • MDR PMS requirements • PMS and PMCF data sources • The PMCF plan • Periodic Safety Update Report • Notified Body expectations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

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