Atonomics Announces ISO 13485 Certification

Important step in commercialization process

Atonomics A/S, Copenhagen

The EN ISO 13485:2012 certification demonstrates that Atonomics has successfully implemented a quality management system that conforms to the standard related to medical device and in-vitro diagnostic manufacturing. 

The ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards. Atonomic’s EN ISO 13485:2012 + AC: 2012 certificate was issued by the notified body, Presafe Denmark A/S.

Atonomics’ EN ISO 13485:2012 + AC: 2012 certificate was awarded by the notified body, Presafe Denmark A/S.

“This certification marks a significant milestone for Atonomics as we continue our transition from an R&D company to a vertically integrated company that is focused on meeting the needs of our customers and all requirements of global manufacturing regulations. Attaining this certification is a planned and important step towards a CE-mark and commercialization of our first product which is expected to be on the market Q2 of 2016.”

Thomas Warthoe, Chief Executive Officer of Atonomics.




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€ 2495 Trace® device                
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We will on a continuous basis release more and more important biomarker capsules.

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From 2018 we will have semi-automated important production procedures and thus can sell at a lower price. 

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