FDA
Safeguard articles tagged "FDA" — guides, analysis, and best practices for software supply chain and application security.
6 articles
Software Transparency Is No Longer Optional for Medical Device Makers
FDA and related regulatory pressure now demands structured SBOMs and real vulnerability disclosure processes. SBOM generation, CSAF and VEX support, and compliance automation help medtech and life sciences teams keep pace.
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.
Safeguard v3: Compliance-First Supply Chain Security
Safeguard v3 adds compliance framework mapping, automated evidence collection, audit-ready reporting, and VEX document support for regulatory readiness.
Healthcare Software Security: HIPAA, SBOMs, and Patient Safety
Medical devices and healthcare IT systems depend on software with hidden vulnerabilities. Here's how SBOMs and supply chain security intersect with HIPAA.
Pharmaceutical Software Validation and Supply Chain Security
Pharma companies must validate software used in drug manufacturing and clinical trials. Software supply chain security is now part of that equation.
SBOM Requirements for Medical Devices: FDA's New Mandate
The FDA now requires software bill of materials for medical device submissions. Here's what manufacturers need to know about compliance.
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