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Arkis BioSciences announces it has received ISO 13485:2016 Certification for its Medical Device Quality Management System

Arkis BioSciences announces it has received ISO 13485:2016 certification for its medical device quality management system by TÜV USA, Inc. (Member of TÜV NORD Group).  Receiving the ISO certification indicates Arkis’ quality management system meets the most current international regulatory requirements necessary for global sales within the medical device industry. “This certification demonstrates our ongoing commitment to quality and international growth and is an important achievement for Arkis.” says Dr. Chad Seaver, Co-Founder and CEO of Arkis BioSciences.  ISO 13485:2016 is an internationally recognized set of regulatory-purposed requirements for medical device quality management systems.

To learn more about ISO 13485 requirements, please visit https://www.iso.org/iso-13485-medical-devices.html.

 

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Arkis BioSciences is ISO 13485:2016 certified for its Medical Device Quality Management System by TUV USA, Inc. (Member of TUV NORD Group).

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