Module 14: Design Development and Certification of Medical Devices

17/11/2023

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

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