Module 14 2022

22/03/2022

Usability and human factors

Increasingly important particularly as devices include ever more functionality. ● Does it work for its intended purpose? ● How has this been confirmed and what factors were assessed?

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

25

Clinical Evidence

Clinical investigations are carried out to: • Establish/Verify performance of the device under normal conditions of use • Establish/Verify the benefits of the device as intended • Establish/Verify clinical safety and determine undesirable effects and whether they constitute acceptable risk when weighed against benefits And may be necessary to confirm clinical benefit/safety of any changes/modifications to the device

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

26

13