Biological Evaluation of Medical Devices

By Jan Peeters, Paul Malinovski

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

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