Per 21 CFR 820.181, the Device Master Record (DMR) includes device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation/maintenance procedures. Since FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026, Part 820 incorporates ISO 13485:2016 by reference and no longer uses the DMR term. The same content now lives in the medical device file required by ISO 13485 clause 4.2.3. Many companies keep the DMR name internally, but documents and audits should map to the ISO 13485 structure.

Why it matters

The DMR is the source of truth for manufacturing. Inadequate DMR control is a common source of FDA Form 483 observations.

Common pitfalls

•Failing to maintain a DMR as a complete and centralized repository can lead to compliance issues.
•Outdated or inaccurate DMR contents can result in manufacturing errors and product non-conformities.
•Inconsistencies between the DMR and actual manufacturing practices frequently lead to regulatory observations.
•Not adequately controlling changes to the DMR can undermine device quality and regulatory compliance.
•A DMR that is difficult to navigate or missing essential information impedes efficient quality management and audits.

Sources

21 CFR 820.181 · eCFR
GHTF/IMDRF Process Validation Guidance · IMDRF/GHTF
FDA - Device Manufacturing · FDA

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.