ISO 13485
**ISO 13485**
What is ISO 13485?
ISO 13485 is an internationally recognized standard for a quality management system (QMS) specific to the medical device industry. It outlines requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is used by medical device manufacturers to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe and effective for their intended purpose.
What other technologies are related to ISO 13485?
ISO 13485 Complementary Technologies
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