Module 14 2022

22/03/2022

A device for extracorporeal photophoresis

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

15

Device Description

Specifications • Design elements that are critical to the device performing its desired function • What tests are performed routinely to ensure device will perform? • What is the acceptable range for these parameters? • What are the standards of the components/container?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

16

8