Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming IVDR and its implications for HFE. During the webinar, the presenters will also cover key considerations when developing specific types of IVD products. Webinar attendees will come away with a greater understanding of how IVDR impacts the HFE work that manufacturers must complete and will attain a “road-map to IVDR compliance” from a human factors perspective.
The webinar was recorded on November 19, 2020.
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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