Module 14: Design Development and Certification of Medical Devices

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22/11/2023

PMCF studies

DESIGN OF PMCF STUDIES • Same requirements for formal protocol • Clarity on the features that are being assessed • Inclusion criteria • Exclusion criteria • Proper statistical input to the design of the study • Human factors / usability assessment included!

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Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

11

PMCF PLAN

At a minimum this should contain :

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

12

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