https://www.medtechcybertips.com/updates FDA, EU MDR, and standards updates affecting medical device cybersecurity. Sponsored by Blue Goat Cyber. en-us https://www.medtechcybertips.com/updates/qmsr-takes-effect https://www.medtechcybertips.com/updates/qmsr-takes-effect Mon, 02 Feb 2026 00:00:00 GMT FDA FDA's Quality Management System Regulation harmonizes Part 820 with ISO 13485. Cyber design controls and CAPA expectations carry over with subtle scoping changes. https://www.medtechcybertips.com/updates/524b-two-year-checkin https://www.medtechcybertips.com/updates/524b-two-year-checkin Wed, 15 Oct 2025 00:00:00 GMT FDA Patterns from recent deficiency letters: weak SBOM hygiene, missing VEX statements, and CVD policies that exist on paper but have no real intake. https://www.medtechcybertips.com/updates/eu-mdr-cyber-annex-update https://www.medtechcybertips.com/updates/eu-mdr-cyber-annex-update Wed, 20 Aug 2025 00:00:00 GMT EU MDR European Notified Bodies are now expecting evidence of IEC 81001-5-1 alignment, not just MDCG 2019-16 narrative. https://www.medtechcybertips.com/updates/site-launch https://www.medtechcybertips.com/updates/site-launch Sun, 01 Jun 2025 00:00:00 GMT Site Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance.