--- title: "MedTech Cyber Tips Editorial Team - Medical Device…" description: "Editorial standards, technical review, and regulatory alignment." 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": "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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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. The team also tracks 510(k) deficiency patterns and CVE trends affecting connected medical devices so guidance on the site stays current. ## Areas of expertise - Medical device cybersecurity - FDA Section 524B - FDA premarket cybersecurity guidance (Feb 3, 2026) - Secure Product Development Framework - SBOM and VEX - Medical device threat modeling - Postmarket vulnerability management - EU MDR cybersecurity (MDCG 2019-16 Rev.2) - EU Cyber Resilience Act - IEC 81001-5-1 - ISO 14971 risk management ## Recent reviewed articles - [ MDCG 2019-16 Rev.2 at six months: Notified Body audit patterns Oct 28, 2026 · EU MDR ](/updates/mdcg-2019-16-rev2-six-month-retrospective) - [ Three years of Section 524B: the deficiencies that never went away Oct 14, 2026 · FDA ](/updates/524b-three-year-checkin) - [ IEC 81001-5-1 Amendment 1 reaches FDIS - what MedTech teams should track Sep 15, 2026 · Standards ](/updates/iec-81001-5-1-amendment-1-fdis) - [ EU CRA delegated acts under Article 27 - the technical baseline is taking shape Sep 2, 2026 · Standards ](/updates/cra-delegated-acts-q3-2026) - [ CISA + FDA joint advisories in 2026: infusion pumps, imaging, and what to do next Aug 5, 2026 · Vulnerability ](/updates/cisa-fda-joint-advisories-mid-2026) ## Topics reviewed - [ Overview Start here. The big picture for MedTech security. ](/topics/home) - [ Why It Matters The case for taking cybersecurity seriously: patients, brand, and revenue. ](/topics/why) - [ SPDF Bake security into every stage of the device lifecycle. ](/topics/spdf) - [ Threat Modeling Identify and reason about threats before they ship. ](/topics/threatmodel) - [ Pentesting What's in scope (hardware, firmware, wireless, cloud, mobile), the methods reviewers expect, and how to read a pentest report against FDA cybersecurity guidance. ](/topics/pentesting) - [ Premarket Submit a cybersecurity package the FDA will accept. ](/topics/premarket) Editorial standards All content on this site is reviewed 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, and the EU Cyber Resilience Act. [Read our standards](/about#editorial-standards) Last site review: July 2026 Elsewhere - [bluegoatcyber.com](https://bluegoatcyber.com/about) 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.