Comparison guide
ISO 27001 vs IEC 81001-5-1
ISO 27001 addresses an organizational information security management system. IEC 81001-5-1 addresses secure health-software lifecycle activities.
Side-by-side breakdown
| Dimension | ISO 27001 | IEC 81001-5-1 |
|---|---|---|
| Scope | Information security management system (ISMS) for an organisation. | Cybersecurity activities for health software across the product lifecycle. |
| Object protected | The organisation's information assets and IT estate. | The medical device's software and the patients/operators using it. |
| Audience | Enterprise IT, security teams, auditors. | Product engineering, regulatory, postmarket security. |
| Premarket evidence relevance | Helpful context but not sufficient for a cyber-device submission. | Direct fit - cited in 2026 premarket guidance as the SPDF reference. |
| Certification model | Third-party ISMS certification; recertified every 3 years. | Conformance assessment per product; no organisational certificate. |
| Common confusion | MedTech buyers often think SOC 2 + ISO 27001 covers their FDA cybersecurity obligation - it does not. | Often missed by IT-led security teams who focus on the enterprise rather than the device. |
When to use which
Review existing access-control, change-management, and supplier-security evidence for possible reuse. Organizational certification does not establish implementation of product-security lifecycle activities.
Define product-security and organizational-security responsibilities within your own governance structure. Assess applicable standards and evidence gaps before planning additional work.
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