Because we pay attention to quality

myoncare is a CE-marked medical device Class IIa (CE0123), according to MDR 2017/745, the quality of which is continuously monitored by our certified quality management system.

myoncare can be customized to fit your needs and requirements* and is continuously improved. To ensure a superior product quality, we’ve implemented a quality management system (QMS) covering all steps of product realization, from the first drafts to post-market surveillance.

Our QMS is certified under the Medical Device Regulation (Regulation (EU) 2017/745 on medical devices) for class IIa medical devices.

In addition, our QMS is certified according to ISO 13485:2016 and is subject to regular internal audits and external audits by our certification body for critical review and continuous improvement.

 

*This applies exclusively to the non-medical partof the product. 

Medical Device Regualtion (mdr)class IIa Certification

QMS Class IIa Medical Device Regulation (1)

QMS Class IIa Medical Device Regulation (2)

Certification EN ISO 13485:2016

EN ISO 13485:2016 (EN)

EN ISO 13485:2016 (DE)