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smk45 replied to the topic When is validation is not required? in the forum Introduction to Design Controls 9 years, 7 months ago
Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability engineering process in order to reduce risks and further ensure that a device can be used safely by patients. By performing human factor studies, the risk of recalls, adverse events, and user errors can be reduced. Additionally, the device should be checked to have safe connections with any accessories and also have functional controls and displays. A human factor study will decrease user reliance on manuals for the device and decrease the need for user training/retraining.