--- title: "ISO 27001, ISO/IEC 27001 | MedTech Terms" description: "International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-27001#term", "name": "ISO/IEC 27001", "alternateName": "ISO 27001", "description": "ISO/IEC 27001:2022 specifies the requirements for an Information Security Management System (ISMS): leadership, planning, support, operation, performance evaluation, and improvement of an organization-wide security program. The companion ISO/IEC 27002:2022 provides a control catalog. 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ISO 27001 is preferred globally; SOC 2 is preferred by US enterprise SaaS customers. Many MedTech companies pursue both because customers ask for them." } }, { "@type": "Question", "name": "Does ISO 27001 cover medical devices?", "acceptedAnswer": { "@type": "Answer", "text": "Not specifically. The ISMS covers organizational security. Product-side security in MedTech is governed by IEC 81001-5-1, AAMI SW96, and FDA's 2023 guidance." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. ISO/IEC 27001 [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)ISO 27001 # ISO/IEC 27001 International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO/IEC 27001:2022 specifies the requirements for an Information Security Management System (ISMS): leadership, planning, support, operation, performance evaluation, and improvement of an organization-wide security program. The companion ISO/IEC 27002:2022 provides a control catalog. Certification is performed by accredited bodies and is often required of MedTech vendors by enterprise customers, hospital systems, and EU procurements. What the regulation says ISO 27001 is not required by FDA for medical-device approval but is heavily used at the corporate-security level. EU GDPR Article 32 and many hospital procurement contracts cite ISO 27001 conformance as evidence of appropriate security measures. ## What this means in practice ISO 27001 covers the \*organization's\* information security; it does not by itself address product cybersecurity. Most MedTech companies pursue ISO 27001 for enterprise risk management and [SOC 2](/terms/soc-2) / customer-trust purposes, while running a separate [IEC 81001-5-1](/terms/iec-81001-5-1) or [AAMI SW96](/terms/aami-sw96) program for the product side. Common pitfalls - • Assuming ISO 27001 satisfies product-side security expectations - it does not. - • Pursuing certification for a marketing badge without integrating the ISMS into operations. ## Frequently asked questions ISO 27001 or SOC 2? Different audiences. ISO 27001 is preferred globally; [SOC 2](/terms/soc-2) is preferred by US enterprise SaaS customers. Many MedTech companies pursue both because customers ask for them. Does ISO 27001 cover medical devices? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity NIST Cybersecurity Framework(NIST CSF) A risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs. ](/terms/nist-csf)[ Cybersecurity NIST SP 800-53 / 800-171(NIST 800-53/171) Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts. ](/terms/nist-800-53)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity) ### More in Cybersecurity · Same category [ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO/IEC· 2 FDA· 1 1. [1 ISO/IEC 27001:2022 Verified ISO/IEC · iso.org ](https://www.iso.org/standard/27001) 2. [2 ISO/IEC 27002:2022 Verified ISO/IEC · iso.org ](https://www.iso.org/standard/75652.html) 3. [3 FDA - Cybersecurity for Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Acronym ISO 27001 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iso-27001) Learn in 60 seconds Card Lesson Quiz International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers. - · ISO 27001 covers the \*organization's\* information security; it does not by itself address product cybersecurity. - · Most MedTech companies pursue ISO 27001 for enterprise risk management and SOC 2 / customer-trust purposes, while running a separate IEC 81001-5-1 or AAMI SW96 program for the product side. - · The companion ISO/IEC 27002:2022 provides a control catalog. Remember this Watch out: Assuming ISO 27001 satisfies product-side security expectations - it does not. Related terms - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [NIST SP 800-53 / 800-171(NIST 800-53/171) ](/terms/nist-800-53) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) You may also need Auto-suggested from Cybersecurity and shared keywords. - [HITRUST CSF(HITRUST) ](/terms/hitrust) - [Threat Modeling ](/terms/threat-modeling) - [AAMI SW96 ](/terms/aami-sw96) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Common Vulnerabilities and Exposures(CVE) ](/terms/cve) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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