SN EN ISO 13485:2016
Current
Current
The latest, up-to-date edition.
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Available format(s)
Hardcopy
Published date
03-01-2016
Publisher
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.
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