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 ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

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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 ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...

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 ...