Module 14 2022

22/03/2022

General Safety and Performance Requirements Checklist

Template available • Tabular format listing the relevant questions for demonstrating the essential requirements of a medical device • Describes how the essential requirements for a medical device have been met based on the development and the information generated • Cross references to the information in the STED file to support each applicable statement

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

23

Non-clinical testing

Has the device been assessed in vitro or in animals? • Provide a summary that describes the assessment • Include the key results • Include the full study report • Conclude how these support the design and performance of the device

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

24

12