ANSI/AAMI/ISO 13485:2016(R2019)
Current
Current
The latest, up-to-date edition.
Medical devices—Quality management systems— Requirements for regulatory purposes
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
10-17-2019
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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