ISO 13485:2016 Revision Fact Sheet

Understanding the basics of ISO 13485 Standard (Medical Device)

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Learn the basics of ISO 13485

ISO 13485 – Medical Device – Quality Management Systems – Requirements for regulatory purpose – address the development, implementation, and maintenance of quality management systems intended for medical device manufacturers, developers, and suppliers.

Download the factsheet that summarizes information related to the ISO 13485:2016 standard and its implementation. Learn more about our ISO 13485 certification services.

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