Module 14: Design Development and Certification of Medical Devices

17/11/2023

Content reflects description throughout

Need to address all aspects: • Is it an active device? • Are the effects transient or long term? • Is it implantable? • Is it sterile?

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? • UDI (Unique Device Identifier)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

16

8