ANSI/AAMI SW96:2023 "Standard for medical device security - Security risk management for device manufacturers" is a normative standard (unlike TIR57's technical report) that specifies cybersecurity activities a manufacturer must perform across the medical-device lifecycle. SW96 is harmonized with IEC 81001-5-1 and IEC 62304 and is positioned as the U.S. counterpart to those international standards.

Why it matters

SW96 is the youngest of the major MedTech cybersecurity references. Teams adopting it typically map its requirements directly into their QMS procedures rather than maintaining a separate security program. SW96 plus 62304 plus 14971 covers most premarket cybersecurity expectations.

Common pitfalls

•Adopting SW96 as a one-time declaration without continuously running its required activities.
•Treating SW96 and IEC 81001-5-1 as redundant - they overlap heavily and can be implemented as one combined procedure.

Sources

FDA Recognized Consensus Standards Database · 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.