Design Controls For Medical Devices


Advanced Care & Alert Portable Telemedical Monitor (AMON)

Wearable medical devices have allowed patients the freedom to perform their normal daily tasks without feeling constricted by their illnesses. Some illnesses like diabetes and atrial fibrillation have forced patients to schedule their lives around dosing medications or performing testing. However, wearable forms of traditional equipment have allowed patients to discreetly monitor their health or […]

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Design Controls for Medical Devices

For medical device design, the US FDA is interested in what is the final finished medical device and the process that led the manufacturer to the final design of the device, the device design process. Specifically, FDA wants manufacturers to ensure that the original user needs are met by the final finished medical device. To […]

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