DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course" training has been added to ResearchAndMarkets.com's offering. This ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug and device manufacturers for failing to meet its current good manufacturing practices (CGMP). Among the violations, ...
Medical device cybersecurity is a dynamic and evolving space. As more devices enter the market and connect to the internet, the risk of these devices being compromised increases—ultimately increasing ...
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
A warning letter released to the public 23 April cites medical device manufacturer Ad-Tech Medical Instrument Corporation for failure to follow medical device regulations established by the US Food ...
Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
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