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.

Why it matters

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.

Sources

ISO/IEC 27001:2022 · ISO/IEC
ISO/IEC 27002:2022 · ISO/IEC
FDA - Cybersecurity for Medical Devices · FDA

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.