Implementing Design Controls for Medical Devices with a Concurrent Engineering Approach

The medical device manufacturers of all classes — class I, class II, and class III devices must establish, follow, and maintain procedures to control the design of the medical devices in order to ensure that the device is safe and meets users’ needs and specified requirements. This blog discusses a step-by-step process of implementing design controls for medical devices with a concurrent engineering approach.

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ABOUT THE AUTHOR

Himanshu Singh