FDA releases final guidance on medical device interoperability

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FDA

The FDA this week released final guidance on interoperability in medical devices – as more healthcare-related electronics connect to the Internet of Things.

“As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange information and use information that has been exchanged becomes increasingly important,” the FDA wrote in an official notice.

The agency outlined recommendations for safer and more secure interactions between devices, recommending that manufacturers design devices with interoperability as a core objective.

The federal watchdog reinforced the necessity of conducting appropriate verification, validation and risk management activities associated with such interoperability, and clear specification of relevant functional, performance and interface characteristics for the user, according to an FDA Voice blog post from FDA Center for Devices and Radiological Health Associate Director for Digital Health Bakul Patel.

Get the full story on our sister site MassDevice.

DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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