Module 14: Design Development and Certification of Medical Devices

17/11/2023

GOOD DESIGN PRACTICE

DESIGN INPUTS ● Must be UNAMBIGUOUSLY: – COMPREHENSIVE – REALISTIC – DEFINED

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

17

GOOD DESIGN PRACTICE

DESIGN INPUTS ● Must identify; – CRITICAL FUNCTIONALITY – PERFORMANCE – SAFETY AND RELIABILITY

– …taking into account the users’ needs and the intended use

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

18

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