ISO/IEC 27001
International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers.
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 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.- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsA risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs.
Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts.
The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
More in Cybersecurity
· Same categoryAAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.
Primary references
3 sources- 1
ISO/IEC 27001:2022VerifiedISO/IECiso.org
- 2
ISO/IEC 27002:2022VerifiedISO/IECiso.org
- 3
FDA - Cybersecurity for Medical DevicesVerifiedFDAfda.gov
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