Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 Define the process  Risk classification of products  Consider appropriate groupings

 Define scope of activity  Where? When? Who? How? What?

 How will you collect. Analyse product safety and performance data?  Fault Log

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Practical Implementation

 Design Risk Assessment  Identify risks of design characteristics and performance  Intended use, intended purpose, intended user

 Process Risk Assessment  Systematic and random failures of production  Materials, Manpower, Machine, Method, Environment

 Application Risk Assessment  Clinical utility  Usability Engineering

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