Updates
What's new in MedTech cyber
Short, dated updates on FDA enforcement, EU MDR/MDCG guidance, standards revisions, and notable vulnerabilities.
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FDA
QMSR replaces 21 CFR 820 — what changes for cybersecurity
FDA'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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FDA
Two years of Section 524B: what FDA reviewers are pushing back on
Patterns 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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EU MDR
MDCG 2019-16 Rev.2 expectations carry into Notified Body audits
European Notified Bodies are now expecting evidence of IEC 81001-5-1 alignment, not just MDCG 2019-16 narrative.
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MedTechCyberTips.com is live
Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance.
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