Module 14: Design Development and Certification of Medical Devices

17/11/2023

Non-clinical testing

Other assessments on the device? • Electrical systems assessments • Software assessments

• Include a summary and separately the full report as described in the IMDRF content guidance

The Organisation for Professionals in Regulatory Affairs

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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

26

13