UNI CEI EN ISO 13485:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Medical devices - Quality management systems - Requirements for regulatory purposes
22-07-2022
13-07-2018
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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