ISO 31000 provides high-level principles and a framework for risk management across an organization - strategy, projects, supply chain, IT - rather than the patient-safety focus of ISO 14971. Its process covers establishing scope and context, risk identification, analysis and evaluation, treatment, monitoring and review, and communication. MedTech companies may use it for enterprise and business risks, such as supply chain or financial risk, alongside ISO 14971 for product safety risk. Unlike ISO 13485, it is guidance and not intended for certification.

Why it matters

Useful for quality leaders building enterprise-level risk programs that cover product, business continuity, and cyber risk in one structure.

Common pitfalls

•Confusing ISO 31000 with a prescriptive regulatory requirement; it is a guideline, not an auditable standard for compliance.
•Attempting to replace ISO 14971 with ISO 31000 for medical device product risk management; the standards are complementary, not interchangeable.
•Implementing ISO 31000 without tailoring its principles to the specific context and risks of a MedTech organization.
•Failing to integrate ISO 31000 principles into existing quality management systems, leading to duplicated or disjointed efforts.
•Overlooking the importance of culture and leadership commitment in successful ISO 31000 implementation, focusing solely on processes.

Sources

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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.