We are shaping the future of healthcare by digitally bridging the gaps between clinics and practices. With our certified platform and a team of medical content experts, we create dedicated solutions for patients, doctors, manufacturers and insurers. Together, we are driving digital transformation for better, connected and accessible medicine.
Our history
2015 - 2018
Foundation of ONCARE and development of the myoncare healthcare platform.
2018 - 2020
Market readiness and first successful projects. Receipt of MDR IIa and ISO 27001 certifications.
2022
Founding of myon.clinic as a provider of full-service solutions that run via the myoncare platform.
2024
Foundation of myon.coach as a joint venture between myon.clinic and the Association of Registered Cardiologists (BNK).
2025 +
Opening up further specialist areas & internationalization with myon.clinic.
The platform myoncare is certified according to MDR (Regulation (EU) 2017/745 on medical devices) for Class IIa medical devices.
ISO 13485: 2016
Quality Management for Medical Devices
This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
ISO/IEC 27001: 2022
Information Security Management System
The information security management of ONCARE is based on the ISO 27001 principles and ensures the security of information assets whether in-house or entrusted to us by our customers.
FDA Approval
myoncare is approved in US according to FDA
The healthcare platform myoncare is approved in the US in accordance with FDA standards.
GDPR Conformity
IITR Certified Data Protection
Our data protection complies with the privacy requirements of the EU GDPR and DSGVO, confirmed and certified by the Institute for IT Law (IITR).
ISO 14971
Application of Risk Management to Medical Devices
The standard describes the processes for identifying the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
IEC 62304
Medical Device Software Lifecycle Processes
The quality management system of ONCARE implements IEC 62304 as a framework throughout the software life cycle processes.
IEC 82304
Health Software Product Safety
The standard applies to the safety and security of stand-alone health software products and points to ISO 14971 and IEC 62304 for risk and SW lifecycle processes.
IEC 62366
Medical Device Usability
Relevant parts of the standard are used during risk management activities and UI/UX design.
Most of the standards and certifications mentioned here refer to the QMS and ISMS of ONCARE GmbH, which is responsible for the development of the myoncare healthcare platform. myon.clinic is a wholly owned subsidiary of ONCARE and builds its services on the myoncare healthcare platform.
