medical-devices
Safeguard articles tagged "medical-devices" — guides, analysis, and best practices for software supply chain and application security.
6 articles
Software Supply Chain Security for Healthcare
From FDA premarket SBOM requirements to a strengthened HIPAA Security Rule and connected medical devices with decade-long lifecycles, healthcare has a distinct supply chain problem. Here is how to build a program that holds up.
FDA Premarket Cybersecurity for Medical Devices 2026
A senior engineer's guide to FDA premarket cybersecurity for medical devices in 2026: section 524B, SBOM expectations, SPDF, and what reviewers actually ask about.
SBOMs in Healthcare: Patient Safety Meets Software Transparency
Healthcare organizations face unique SBOM challenges driven by FDA requirements, device lifecycles, and patient safety stakes.
Healthtech FDA Software Supply Chain Guidance
The FDA's cybersecurity guidance has quietly turned into one of the most consequential supply chain regulations in US software. A walkthrough for engineering teams shipping connected medical products.
Medical Device SBOM Requirements in Practice
SBOMs for medical devices look straightforward on paper and get complicated fast in the real world. A field report on what regulators actually accept and what engineering teams actually produce.
FDA Premarket Cybersecurity SBOM in 2026
What the FDA's 2026 premarket cybersecurity guidance actually requires for SBOMs, how reviewers evaluate them, and the patterns that cause 510(k) submissions to stall.
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