Module 14 2022

22/03/2022

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

9