The Global Guide to Human Factors and Usability Engineering Regulations

MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being introduced by regulatory authorities to support further innovation.

The regulatory landscape impacts both product development activities and commercialization timelines.

In this True Quality Summit Series, we’re taking a tour around the world and diving into the state of regulations, upcoming critical events, and what you can expect in the future.

★ KEY VIDEO TAKEAWAY★

The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product.

This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

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