Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

DESIGN INPUTS – considerations ● TARGET PRODUCT PROFILE (TPP) – Instructions for Use (IFU) – Usability / human factors studies ● Device CLASSIFICATION and guidances – EU, USA, IMDRF etc

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

19

GOOD DESIGN PRACTICE

DESIGN INPUTS – considerations ● ERGONOMIC requirements ● GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHECKLIST – Identify the ISO STANDARDS relevant to the device

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

20

10