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    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 CyberLast 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 / customer-trust purposes, while running a separate IEC 81001-5-1 or 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

    Different audiences. ISO 27001 is preferred globally; SOC 2 is preferred by US enterprise SaaS customers. Many MedTech companies pursue both because customers ask for them.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    ISO/IEC·2FDA·1
    1. 1
      ISO/IEC 27001:2022
      Verified
      ISO/IECiso.org
    2. 2
      ISO/IEC 27002:2022
      Verified
      ISO/IECiso.org
    3. 3
      FDA - Cybersecurity for Medical Devices
      Bot-blocked
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.