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Quality & Risk

Quality System Regulation(QSR / 21 CFR 820)

In one line

FDA's current good manufacturing practice (cGMP) requirements for medical devices.

Definition

The Quality System Regulation (21 CFR Part 820) sets out the cGMP requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use.

Why it matters

FDA has harmonized the QSR with ISO 13485:2016 in the Quality Management System Regulation (QMSR), which becomes effective in 2026. Manufacturers must align procedures with the new framework.

Sources

Quality System Regulation (21 CFR 820) · eCFR
QMSR Final Rule · FDA
FDA - Quality Systems · FDA

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Standards

ISO 13485

In one line

International standard for medical device quality management systems.

Definition

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Why it matters

ISO 13485 is referenced or required by regulators worldwide, including the EU (under MDR/IVDR) and Health Canada. FDA's QMSR explicitly incorporates ISO 13485:2016 by reference.

Sources

ISO 13485:2016 · ISO
FDA Recognized Consensus Standards · FDA
ISO Standards Catalogue - Health · ISO

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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.