Module 14: Design Development and Certification of Medical Devices

17/11/2023

Device Description

Describe the device clearly and in detail • What it looks like • How it works • What it is used for • Classification, and how this was determined – which rule Pictures are helpful for a reviewer Avoid minor details that may change regularly (e.g. …with a blue connection port)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

13

A device for extracorporeal photophoresis

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

14

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