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The regulatory landscape impacts both product development activities and commercialization timelines.
In this True Quality Summit Series, we travel around the world and dive into the state of regulations, upcoming critical events and what you can expect in the future.
KEY VIDEO TAKEAWAY
The regulatory landscape regarding human factors and usability engineering has continued to evolve since the FDA released draft guidance over a decade ago. In fact, the international standard for usability engineering, IEC 62366-1:2015, was only amended in 2020. The good news is that the path to a successful regulatory strategy regarding human factors and usability engineering has never been clearer. Regulators have spoken in the form of guidance and standard documents. All that's left for you to do is understand everything as it relates to your specific device or product.
This presentation originally aired during the Global MedTech Regulatory Trends Virtual Summit 2022.
To watch more related videos, browse the full list of free replays of this track from the virtual summit event: https://youtube.com/playlist?list=PLkchw-at8PkO6SuXLY28UOnbNLVYslZaU
You can also download the slides for this presentation for free here:
https://www.slideshare.net/greenlightguru/presentations
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