AAMI TIR57:2016 "Principles for medical device security - Risk management" is a technical information report that adapts general security risk-management principles to medical devices, with explicit bridges to ISO 14971 (safety risk management) and IEC 80001 (network risk). TIR57 is the MedTech-specific reference for integrating cybersecurity risk into the existing safety risk management file rather than running it as a separate process.

Why it matters

TIR57 is most useful as the bridge document that lets MedTech risk and security teams speak the same language. Together with TIR97 (post-market security risk management) it forms the AAMI cybersecurity playbook.

Common pitfalls

•Treating cybersecurity risk and safety risk as parallel processes producing two different files.
•Ignoring TIR97 for post-market - TIR57 is the design-side reference, TIR97 covers the operational side.

Sources

FDA Cybersecurity Guidance (Sept 2023) · FDA
HSCC - Health Sector Coordinating Council · HSCC
CISA - Healthcare and Public Health Sector · CISA

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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.