IEC 62366-1:2015 specifies a process for a manufacturer to analyze, specify, develop, and evaluate the usability of a medical device as it relates to safety, addressing use errors that could lead to harm. The process covers preparing the use specification, identifying user interface characteristics related to safety, identifying hazards and hazardous situations from use, selecting hazard-related use scenarios, establishing a user interface specification and evaluation plan, and performing formative and summative evaluations. Amendment 1:2020 updated the standard. IEC TR 62366-2 provides additional guidance, and FDA's human factors guidance takes a broadly similar approach.

Why it matters

Usability engineering and human factors validation are required by FDA and EU MDR. Failure to adequately address use-related risks is a frequent cause of submission deficiencies and post-market events.

Common pitfalls

•Ignoring human factors early in the design process can lead to costly redesigns and delays in market approval.
•Failing to adequately document usability engineering activities can result in regulatory deficiencies.
•Confusing user interface testing with comprehensive human factors validation can leave critical use errors unaddressed.
•Underestimating the diversity of users and use environments can lead to an incomplete understanding of potential use-related risks.

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.