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ISO13485

ISO13485

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**ISO13485**

What is ISO13485?

ISO 13485 is an internationally recognized quality management system standard specifically for the medical device industry. It outlines the 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. It is commonly used by medical device manufacturers to ensure the safety, quality, and efficacy of their products, and to meet regulatory requirements in various markets.

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