iso 13485 certification

iso 13485 certification

ISO 13485 is an international quality management system (QMS) standard for the design and manufacture of medical devices. The standard is based on the ISO 9001 quality management system and is designed to help medical device organizations meet regulatory requirements for the design and manufacture of safe and effective medical devices. ISO 13485 certification is a validation demonstrating that a company has a QMS in place that meets the requirements of the ISO 13485 standard.

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