A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA. Nonconforming product must be identified, documented, segregated and evaluated so it cannot be used by mistake, as required by ISO 13485 clause 8.3. The evaluation decides whether an investigation is needed and who can approve the disposition. 'Use as is' and concession decisions need justification and records. When product is found nonconforming after delivery, the manufacturer must act on the effects, which can lead to a field action or recall.

Why it matters

Trend analysis of NCRs is a key feedback loop into design and process improvements.

Common pitfalls

•Confusing a nonconformance with a deviation; a nonconformance indicates failure to meet a requirement, while a deviation is a departure from an approved procedure without necessarily failing a requirement.
•Failing to adequately investigate the root cause of nonconformances, which can lead to recurrence and persistent quality issues.
•Treating all nonconformances with the same level of urgency rather than prioritizing based on risk to patient safety or product quality.
•Not integrating nonconformance data into broader quality system processes like management review, risk management, and CAPA.
•Failing to ensure that disposition actions for nonconforming product are properly implemented and verified.

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.

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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.