Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique challenges because their products are subject to HFE requirements for devices, drugs, cosmetics, or more. In this webinar, we will provide an overview of HFE considerations for combination products. You will learn:
ABOUT THE PRESENTER
Frauke Schuurkamp received her B.S. in Applied Psychology from the Saxion University of Applied Sciences and her M.S. in Human Factors & Media Psychology from the University of Twente. After completing her human factors training she joined the HFRD team, where she contributes to user research and usability testing projects.
新欧盟体外诊断器械法规(IVDR,In Vitro Diagnostic Device Regulation (EU) 2017/746)IVDR的发布为体外诊断器械医疗器械制造商满足欧洲市场合规带来新规实施、新旧过渡的诸多前所未有的挑战。对此,全球医疗器械及IVD器械合规专家Emergo b
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