Safety and Human Factors Engineering in Medical Device Design

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety standards mandated by the general standard, IEC 60601-1, updated to the 3rd edition, and now Amendment No. 1 to that standard, require testing and verification of devices and essential performance, while particular standards focused on specific types of devices add considerations that must be met.