Page 252 - Safety Risk Management for Medical Devices
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Special Topics 231
33.4 RISK MANAGEMENT FOR COMBINATION MEDICAL DEVICES
For combination medical devices, which combine device, drug, or biologics, a good
strategy is to first do analysis of risks for each aspect of the combination device, i.e.,
device part, drug part, and biologic part, and then analyze for the risks due to the
interaction of the parts, such as drug with device. Then bring it all together in the
Risk Assessment and Control Table and determine the overall residual risk.
