• Fubin Wu

What is Safety Engineering for Medical Devices?

Safety engineering is a system engineering discipline which assures that engineered systems provide acceptable levels of safety. Medical device safety engineering assures that a medical device behaves safely while delivering clinical benefits thru providing needed clinical functions for its intended use (does what it should do and does not do what it should not do). Lack of understanding of safety engineering can lead to unsafe device and delay or increased costs for device development and life cycle maintenance.

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​“Safety means that, for a given medical device with a defined intended use (including intended patient population) and use specification, which is both verified and validated, reasonable assurance ex