Mark Crawford, Contributing Writer03.07.19
An ever-evolving regulatory landscape, combined with increasingly complex and diverse medical devices, has challenged the testing protocols for many medical device manufacturers (MDMs). More companies want improved validation and accreditation processes, especially for pre-clinical device safety testing. Validation of cleaning, disinfection, and sterilization processes for many medical devices is already an ongoing improvement process. In addition, biocompatibility requirements are updated so frequently that it is hard for MDMs and their contract manufacturers (CMs) to keep up.
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
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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