Per 21 CFR 820.50 and ISO 13485 Section 7.4, manufacturers must evaluate, select, and monitor suppliers based on the supplier's ability to meet specified requirements. Under the QMSR, these requirements come from ISO 13485 clause 7.4, with controls proportionate to the risk of the supplied product. Typical tools include supplier audits, quality agreements, approved supplier lists, incoming inspection and scorecards. The EU MDR also expects notified bodies to audit critical suppliers and crucial subcontractors, sometimes unannounced.

Why it matters

Supplier audits, agreements, and incoming inspection comprise the typical control set. Supply chain risk now includes cybersecurity concerns for software suppliers.

Common pitfalls

•Failing to document the rationale for supplier selection and evaluation can lead to non-conformities during audits.
•Assuming that a supplier's certification to a quality standard, like ISO 9001, automatically fulfills all MedTech regulatory requirements is a common mistake.
•Neglecting to periodically re-evaluate suppliers, especially after changes in their processes or products, can result in compromised product quality.
•Not having clear quality agreements in place with suppliers can lead to disputes regarding responsibilities and specifications.
•Overlooking cybersecurity requirements for software and IT suppliers can introduce significant risks to medical devices and patient data.

Sources

21 CFR 820.50 · eCFR
GHTF/IMDRF Process Validation Guidance · IMDRF/GHTF
FDA - Device Manufacturing · FDA

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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.