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CATÉGORIE: QUALITY SYSTEMS
QMSR (Réglementation du système de management de la qualité)
La réglementation FDA mise à jour (effective 2026) remplaçant la QSR en incorporant ISO 13485:2016 par référence.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
FDA’s Quality Management System Regulation (QMSR) modernizes device quality system requirements, aligning more closely with ISO 13485 while retaining FDA inspection authority.
PROCESS / STEPS
- Gap-assess current QSR procedures vs QMSR/ISO 13485 expectations.
- Update SOPs, training, and internal audits.
- Prepare inspection readiness under the new framework.
- Monitor FDA transition timelines and enforcement communications.
EXAMPLES
- Manufacturers already certified to ISO 13485 still need FDA-specific processes (e.g., certain reporting interfaces).
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to QMSR (Réglementation du système de management de la qualité) across 27 authorities in real time.
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