Module 19 2021

02/06/2021

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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