ISO 14971:2019 specifies terminology, principles, and a process for risk management of medical devices, including software and in-vitro diagnostics, throughout the device lifecycle. The process runs through a risk management plan, risk analysis (intended use, hazards, hazardous situations), risk evaluation against predefined criteria, risk control, evaluation of overall residual risk, a risk management review and production and post-production activities. The 2019 edition added explicit treatment of benefits and data and system security as sources of hazards. It is recognized by FDA and harmonised in the EU as EN ISO 14971:2019 with Amendment A11:2021.

Why it matters

Risk management per ISO 14971 underpins design controls, cybersecurity risk decisions, post-market surveillance, and benefit-risk determinations expected by FDA, EU notified bodies, and other regulators.

Common pitfalls

•Treating risk management as a one-time activity at the beginning of the device lifecycle rather than an ongoing, dynamic process that continues through post-production.
•Focusing solely on safety risks and neglecting other critical aspects like data security, usability risks, or the balance of benefits versus risks, as explicitly highlighted in the 2019 revision.
•Failing to adequately document the risk management process, including risk analysis, evaluation against predefined criteria, control measures, and the assessment of overall residual risk, which is crucial for regulatory submissions.

Sources

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.