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.




Trace® is now ready for ordering

€ 2495 Trace® device                
€ 15 each Lipids capsule  
€ 120 for 10 Lipids capsules

We will on a continuous basis release more and more important biomarker capsules.

Trace is available now for you that wishes to get started with this important biomarker monitoring device.

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

We allow you to pre-order now for below pricing with delivery time before end of April 2018.

€ 695 Trace® device
€ 15 each Lipids capsule or
€ 120 for 10 Lipids capsules

Orders will be shipped on a first incoming order basis.

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