What ISO 13485 (Medical QMS) requires
ISO 13485:2016 is the global standard for Medical Device Quality Management Systems (QMS). It specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Pillar: Medical & Healthcare · Authority: ISO (International Organization for Standardization) · Version: 1.1.0 · Last updated:
Primary source: https://www.iso.org/standard/59752.html
SHA-256 integrity: ff41376dcd9ee61a3da6f4ac83e88db34ff30e8def02baef82322e647b16c842
Primary Citations — 6 traced to source
- {"citation_id":"EU MDR 2017/745","description":"Regulation (EU) 2017/745 on medical devices. ISO 13485:2016 is a harmonized standard providing a presumption of conformity with the QMS requirements detailed in Annex IX.","url":"https://eur-lex.europa.eu/eli/reg/2017/745/oj"}
- {"citation_id":"US FDA 21 CFR Part 820","description":"The US FDA's Quality System Regulation (QSR). The FDA is currently harmonizing this regulation with ISO 13485, creating the proposed Quality Management System Regulation (QMSR).","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820"}
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