Module 14: Design Development and Certification of Medical Devices

17/11/2023

The “Waterfall” flow chart (you will see this again!_)

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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GOOD DESIGN PRACTICE

DESIGN INPUTS ● What are they? – PHYSICAL AND PERFORMANCE REQUIREMENTS THAT ARE THE BASIS FOR PRODUCT DESIGN

– THE INTENTIONS FOR YOUR DEVICE

– THEY ARE NOT SOLUTIONS

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

16

8