Module 14: Design Development and Certification of Medical Devices

17/11/2023

GOOD DESIGN PRACTICE

DESIGN PLANNING ● TOOLS

– GANTT CHARTS / PERT CHARTS – CHECKLISTS – STANDARDS AND GUIDELINES

● TIMESCALES – ? If everything works out how long will it take (best case) – ? What’s the most likely duration? (most probable) – ? If almost everything goes wrong how long will it take (worst case)

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

13

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

14

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