Expert analysis on medical device cybersecurity
Regulatory updates, standards guidance, and practical takeaways for medical device and health IT manufacturers.
Cybersecurity in Quality: FDA's Guidance on Computer Software Assurance
FDA's Computer Software Assurance (CSA) guidance changes how manufacturers should validate the computers and automated systems used in production and quality operations.
Sep 26, 2025CISA Publishes Draft Update on SBOM Minimum Elements
CISA's 2025 draft update to the Software Bill of Materials minimum elements builds on the 2021 NTIA standard, with implications for medical device supply chain transparency.
Sep 12, 2025Microsoft Windows 10 End of Life: What It Means for Medical Devices?
Microsoft ended Windows 10 support on October 14, 2025 — a decade-long lifecycle closing that raises cybersecurity and regulatory concerns for connected medical devices still running it.
Sep 9, 2025Cybersecurity requirements for FDA Submission
A practical outline of the cybersecurity documentation and requirements medical device manufacturers need for PMA or 510(k) submissions.
Aug 21, 2025FDA publishes new premarket cybersecurity guidance (June 2025)
FDA's June 27, 2025 guidance on Cybersecurity in Medical Devices replaces the 2023 version, incorporating draft updates and additional new requirements.
Aug 21, 2025