A hazard is a potential source of harm. A hazardous situation describes circumstances in which people, property or the environment are exposed to a hazard. Harm is injury or damage to health, property or the environment. These are distinct points in a risk-management analysis, not interchangeable labels. A sequence of events can lead from a hazard to exposure and then to harm. Risk combines the probability of occurrence of harm and its severity. For an illustrative medical device example, electrical energy is a potential source, contact with an energized accessible part is the exposure situation, and an electrical burn is a possible harm. This summary is educational; consult the licensed ISO 14971 text for normative definitions and application.

Why it matters

In a risk analysis, record the potential source of harm, the sequence of events, the exposure situation and each possible injury separately. A component failure is an event; it is not automatically a hazard or a harm. Keeping these distinctions visible helps a team explain why a control addresses a particular point in the sequence. For an illustrative electrical scenario, insulation damage could make a conductive surface live. Contact with that surface is a hazardous situation, and an electrical burn is a possible harm. The same potential source can produce different outcomes depending on who is exposed and how the device is used. Do not assign a single injury to every failure without examining the actual sequence. When selecting controls, ask which event or exposure the proposed design change addresses, what evidence demonstrates its effect and whether it introduces another risk. Record the rationale in the risk-management file and revisit it when field information changes the assumptions. This is an educational workflow, not a substitute for the licensed ISO 14971 requirements.

Common pitfalls

•Using a failure mode, hazard and patient harm as interchangeable labels.
•Skipping the hazardous situation and moving directly from a component defect to injury.
•Assuming the probability of a software fault is the probability of patient harm.
•Assigning exact ISO clauses without consulting the licensed standard.
•Claiming a control eliminates all risk without evidence and residual-risk analysis.

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.