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T 64v19D - Free demo course E-Learning - ISO 14971 Risk management of medical devices version 2019
Presentation T 64
MCT Beginning T 64
1 Risk T 64
2 Definitions, ... T 64
3 Process approach T 64
4 General requirements T 64
Summary of clause 4 T 64
MCT General requirements T 64
5 Risk analysis
Summary of clause 5
MCT Risk analysis
6 Risk evaluation
Case: New risk
Case: Risk register
Case: Risk treatment
Summary of clause 6
7 Risk control
Case: Kaizen and problem
Case: Control measure
Case: Acceptability criteria
Summary of clause 7
MCT Risk evaluation
8 Overall residual risk
Summary of clause 8
9 Risk management ...
Case: Design review
Summary of clause 9
MCT Management review
10 Production ...
Case: Nonconformities
Summary of clause 10
MCT Production and ...
MCT End
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