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 part of the product. 

patientendaten, patientendashboard, ärztesoftware, digital health, telemedizin, digitale sprechstunde, gesundheitsmonitoring

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

myoncare, CE-gekennzeichnetes Medizinprodukt MDR Klasse IIa, TÜV

EN ISO 13485:2016 (EN)

EN ISO 13485:2016 (DE)

Certification EN ISO 27001: 2017