The Medical Device Regulation (MDR) and human factors


At the end of January, Auxergo joined a webinar on The Medical Device Regulation (MDR) and human factors. The MDR has introduced key changes for human factors and usability engineering compliance, with the emphasis now moving from approval based to life cycle based. This covers design and manufacture as well as the information provided with the device. In the new rules, human factors should be applied to all medical devices regardless of classification. In the medical device R&D process, human factors along with use-related risk management must be implemented as an iterative process. User interfaces and displays must also be validated for readability, comprehension and usability. Furthermore, the usability of the software as a medical device (SaMD) should be considered. A webinar about SaMD can be found in our previous post: https://www.auxergo.com/post/software-as-a-medical-device-webinar. Finally, after release, there should be surveillance to gather post-market usability data.

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