UNE-EN ISO 13485:2018
Current
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
07-25-2018
Publisher
This International Standard 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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