Module 14: Design Development and Certification of Medical Devices

17/11/2023

GOOD DESIGN PRACTICE

DESIGN INPUTS ● INTERNALLY IMPOSED GSP REQUIREMENTS – Based on market research – Clinical trials – Competitor products – Contractual requirements ● EXTERNALLY IMPOSED GSP REQUIREMENTS – CUSTOMER NEEDS – STATED AND IMPLIED – REGULATORY / STATUTORY – ENVIRONMENTAL requirements

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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GOOD DESIGN PRACTICE

DESIGN INPUTS ● HUMAN FACTORS STUDIES – Nowadays more important than ever

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

22

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