Both ISO and the FDA have emphasized risk management in developing testing protocols for medical devices. In 2018, ISO guideline 10993-1 was updated and continues to emphasize risk management. With these and other regulatory changes, it has never been more critical for MDMs and CMs to stay informed. For example, the upcoming Medical Device Regulation (MDR) in Europe has reclassified many products, “making it necessary to look at performing testing to keep these products on the market,” said Audrey Turley, senior biocompatibility expert for Nelson Labs, a Salt L
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