Module 14: Design Development and Certification of Medical Devices

22/11/2023

Design change management

• All changes analysed, supported and DOCUMENTED

• in the same way as during the initial design and development phases.

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

13

Design change management

• DESIGN CHANGES • Always validated and tested!

• HUMAN FACTORS STUDIES • Bridging studies • REPEAT STUDIES

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

14

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