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.

2015

IEC 62366-1

FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices

FDA – Medical Devices

2016

FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.

FDA – Combination Devices

2017

MHRA Guidance: Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products v1.0.

MHRA HFE Guidance

2017

FDA Guidance: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-device Combination Product submitted in an ANDA.

FDA – Generic Devices

2018

Packaging for terminally sterilised medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.

ISO 11607 1:2019

2019

European Medical Device Regulation, 2017/745/EC.

EU MDR 2017/745/EC

2020

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development