QUALITY

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

Because we pay Attention to quality

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 audits by our certification body for critical review and continuous improvement.

Medical device regualtion (mdr)class iia certification

QMS Class IIa Medical Device Regulation (1)

QMS Class IIa Medical Device Regulation (2)

Certification after din en iso 13485: 2016

EN ISO 13485:2016 (EN)

EN ISO 13485:2016 (DE)