ISO/TR 24971:2020 provides guidance on developing, implementing, and maintaining a risk management system per ISO 14971, including hazard identification, risk control, residual risk evaluation, and post-production information. Because it is a technical report, it gives guidance and examples rather than requirements. Annexes cover topics such as identifying hazards and characteristics related to safety, techniques like FMEA and fault tree analysis, risk management for IVDs, and security-related risks. Much of the informative guidance that was in annexes of older editions of ISO 14971 was moved into TR 24971 in 2020.

Why it matters

TR 24971 is the de facto playbook for executing ISO 14971 in practice and is frequently referenced by auditors and notified bodies.

Common pitfalls

•A common pitfall is treating ISO/TR 24971 as a standalone requirement rather than as guidance for implementing ISO 14971.
•Manufacturers sometimes fail to periodically review and update their risk management processes based on the evolving recommendations in ISO/TR 24971.
•Overlooking the interconnectedness between risk management activities and other quality system elements, such as design control or post-market surveillance, is a frequent mistake.

Sources

ISO/TR 24971:2020 · ISO
FDA Recognized Consensus Standards · FDA
ISO Standards Catalogue - Health · ISO

Open full page

Select term B to compare.

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.