On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...
On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) ...
Eurofins Medical Device Services North America, part of a global network of over 20 medical device testing laboratories and a leading medical device solutions partner, recently launcheda GMPPFAS ...
The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
The world of medical devices is rapidly changing. In place of disconnected, simple medical devices, a new world of complex software both on and off the now-connected device is providing a larger ...
The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...
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