--- title: "MedTechCyberTips.com is live" description: "Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance." lang: en json-ld: | [ { "@context": "https://schema.org", "@graph": [ { "@type": "WebSite", "@id": "https://medtechcybertips.com/#website", "url": "https://medtechcybertips.com/", "name": "MedTech Cyber Tips", "description": "The ultimate organized guide to medical device cybersecurity.", "inLanguage": "en-US", "publisher": { "@id": "https://medtechcybertips.com/#org" }, "potentialAction": { "@type": "SearchAction", "target": "https://medtechcybertips.com/topics?q={search_term_string}", "query-input": "required name=search_term_string" } }, { "@type": "Organization", "@id": "https://medtechcybertips.com/#org", "name": "MedTech Cyber Tips", "url": "https://medtechcybertips.com/", "logo": "https://medtechcybertips.com/icon-512.png", "sponsor": { "@type": "Organization", "name": "Blue Goat Cyber", "url": "https://bluegoatcyber.com", "sameAs": [ "https://home.bluegoatcyber.com/", "https://codebluechart.com/", "https://why.bluegoatcyber.com/", "https://spdf.bluegoatcyber.com/", "https://threatmodel.bluegoatcyber.com/", "https://pentesting.bluegoatcyber.com/", "https://premarket.bluegoatcyber.com/", "https://fdaresponse.bluegoatcyber.com/", "https://postmarket.bluegoatcyber.com/", "https://goatwatch.bluegoatcyber.com/" ] } } ] }, { "@context": "https://schema.org", "@type": "BlogPosting", "headline": "MedTechCyberTips.com is live", "description": "Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance.", "datePublished": "2025-06-01", "dateModified": "2025-06-01", "url": "https://medtechcybertips.com/updates/site-launch", "mainEntityOfPage": "https://medtechcybertips.com/updates/site-launch", "author": { "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team" }, "reviewedBy": { "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team" }, "publisher": { "@type": "Organization", "name": "MedTech Cyber Tips", "url": "https://medtechcybertips.com", "sponsor": { "@type": "Organization", "name": "Blue Goat Cyber" } }, "articleSection": "Site" }, { "@context": "https://schema.org", "@type": "Person", "@id": "https://medtechcybertips.com/authors/editorial-team", "url": "https://medtechcybertips.com/authors/editorial-team", "name": "MedTech Cyber Tips Editorial Team", "jobTitle": "Medical Device Cybersecurity Editors", "description": "The MedTech Cyber Tips editorial team is a group of practitioners with hands-on experience across FDA premarket cybersecurity submissions, Secure Product Development Framework (SPDF) implementation, medical device threat modeling, and postmarket vulnerability management. Every article, checklist, and update on this site is reviewed for accuracy against the FDA's February 3, 2026 final premarket cybersecurity guidance, Section 524B of the FD&C Act, MDCG 2019-16 Rev.2, IEC 81001-5-1, ISO 14971, and the EU Cyber Resilience Act. 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Reviewed by [MedTech Cyber Tips Editorial Team](/authors/editorial-team) · Published Jun 1, 2025 · Last reviewed July 2026 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 - [ MDCG 2019-16 Rev.2 at six months: Notified Body audit patterns Six months in, Notified Body audits under MDCG 2019-16 Rev.2 show three clear failure modes - narrative-only SBOMs, CVD policies without operational evidence, and traceability gaps between security risk controls and design outputs. Oct 2026](/updates/mdcg-2019-16-rev2-six-month-retrospective) - [ Three years of Section 524B: the deficiencies that never went away Three-year retrospective on Section 524B enforcement: SBOM depth, VEX justification, and CVD operational evidence remain the top three categories of cyber deficiencies. Two new patterns emerged in 2026 - AI/ML threat-model gaps and weak end-of-support labeling. Oct 2026](/updates/524b-three-year-checkin) - [ IEC 81001-5-1 Amendment 1 reaches FDIS - what MedTech teams should track Amendment 1 to IEC 81001-5-1 (health software security lifecycle) is in Final Draft International Standard ballot. It sharpens SBOM, CVD, and postmarket vulnerability expectations - and it's the standard EU Notified Bodies are quietly aligning MDCG 2019-16 audits against. Sep 2026](/updates/iec-81001-5-1-amendment-1-fdis) MedTech Cyber Tips The organized, end-to-end guide to medical device cybersecurity, from concept through postmarket. Part of the Blue Goat Cyber family. Topics - [Overview](/topics/home) - [Why It Matters](/topics/why) - [SPDF](/topics/spdf) - [Threat Modeling](/topics/threatmodel) - [Pentesting](/topics/pentesting) Reference - [Glossary](/glossary) - [FDA vs MDR](/compare) - [Resources](/resources) - [Updates](/updates) - [RSS feed](/rss.xml) © 2026 medtechcybertips.com. An educational resource sponsored by Blue Goat Cyber. Not legal or regulatory advice.