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 ...

As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...

The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

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 ...

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