ADVANTAGES

There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increase. Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device.

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