ANSI AAMI ISO 13485-2016

Category: Technical

Posted on 2020-09-14, by banz.


Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes.
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 requirements and regulatory requirements applicable to medical devices and related services.

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ANSI AAMI ISO 13485-2016

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