Module 14: Design Development and Certification of Medical Devices
17/11/2023
ISO 10993
Masterclass: Lecture 1
The Organisation for Professionals in Regulatory Affairs
35
GOOD DESIGN PRACTICE
DON’T FORGET!
OTHER REGULATORY INTERFACES
● THE MACHINES DIRECTIVE
● THE PERSONAL PROTECTIVE EQUIPMENT DIRECTIVE
Masterclass: Lecture 1
The Organisation for Professionals in Regulatory Affairs
36
18
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