What is ISO 13485?


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Anil Chaudhari Profile
Anil Chaudhari , CEO, Operon Strategist, answered

ISO 13485 is a QMS(Quality Management System) required for a medical device for regulatory purpose. ISO 13485 was published in 1996 by International Organization for Standardization (ISO). ISO 13485: 2016 is the latest version of ISO 13485. If you are a medical device manufacturer and want to market your medical device then you must have ISO 13485 QMS for your medical device

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