The FDA is taking steps to update its Medical Device Reporting (MDR) Program, one of the tools the agency uses to monitor device performance, detect potential device-related safety concerns or signals, and contribute to the benefit-risk assessment of these products.
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Cybersecurity provider CSPi and Seceon have linked up to develop a product to address one of the biggest security challenges related to the Internet of Things (IoT): where endpoint detection and response applications and other bolt-on security services cannot be deployed on IoT devices.
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After months of debate regarding the difference between medical device servicing and remanufacturing, the U.S. FDA is planning to publish a draft guidance document on the subject by September 30, an official for the agency revealed during AAMI Exchange 2019.
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In May, a manufacturer of a non-OEM AED replacement battery received a Warning Letter from the FDA, following an inspection that occurred last November. Here, educator William Hyman breaks down the implications this could have for the industry.
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During the revamped AAMI Exchange 2019, which took place from June 7-10 at Cleveland’s Huntington Convention Center, experts in the healthcare technology management field explored a variety of key issues. Here are some of them.
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