We launched MedTech Cyber Tips as a vendor-neutral, organized walk-through of medical device cybersecurity. Every topic maps to the lifecycle phase where it matters most, every tip is actionable, and every acronym links to a plain-English glossary entry.
More updates
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QMSR replaces 21 CFR 820 — what changes for cybersecurityFDA's Quality Management System Regulation harmonizes Part 820 with ISO 13485. Cyber design controls and CAPA expectations carry over with subtle scoping changes.
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Two years of Section 524B: what FDA reviewers are pushing back onPatterns from recent deficiency letters: weak SBOM hygiene, missing VEX statements, and CVD policies that exist on paper but have no real intake.
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MDCG 2019-16 Rev.2 expectations carry into Notified Body auditsEuropean Notified Bodies are now expecting evidence of IEC 81001-5-1 alignment, not just MDCG 2019-16 narrative.