Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 Use tools appropriate to device and approach  Preliminary Hazard Analysis (PHA)  Fault Tree Analysis (FTA)  Failure Mode and Effects Analysis (FMEA)  Hazard and Operability (HAZOP)  Hazard Analysis and Critical Control Point (HACCP)  Other....

A

F

G

B

E

H

I

C

D

 Use more than one approach...

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Practical Implementation

 Use of Fault Log  Non Conformances

 Customer Complaints  Out of Specifications  QMS metrics (post market surveillance)

 Risk estimation needs continuous review and verification

 Link risk management to existing QMS processes

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