Module 14: Design Development and Certification of Medical Devices
What are the current Human Factors and Usability Engineering regulations?
Medical Devices: Application of Usability Engineering to Medical Devices.
MHRA HFE Guidance
2021
FDA Guidance: Content of Human Factors Information in Medical Device Marketing Submissions.
FDA – Marketing Submissions
2022
NMPA Draft Guidance: The application of human factors and usability engineering to medical devices.
NMPA – HFE Guidance
2023
? (Watch this space!)
2024
?
FDA – Generic Devices As seen, there are always new requirements and regulations to meet that require manufacturers to provide evidence of use safety and effectiveness. This is unlikely to change in the future. 2018
ISO 11607 1:2019
2019
EU MDR 2017/745/EC
2020
The Organisation for Professionals in Regulatory Affairs
Human Factors and Usability Testing during development
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