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CATEGORY: STANDARDS
ISO 13485
The international standard specifying QMS requirements for organizations involved in the design, production, installation, and servicing of medical devices. ISO 13485:2016 is the current version and is harmonized with EU MDR.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
ISO 13485 is the core QMS standard for medical device organizations across design, manufacture, and service. It underpins NB audits, MDSAP, and many market registrations.
PROCESS / STEPS
- Scope processes covering product realization and regulatory requirements.
- Document procedures for design controls, CAPA, purchasing, production, and PMS interfaces.
- Train personnel; run internal audits and management review.
- Certify with an accredited body if required by markets/customers.
EXAMPLES
- Contract manufacturers typically maintain ISO 13485 certification to supply OEMs.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to ISO 13485 across 27 authorities in real time.
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