Your pathway to streamlined medical device development. With pre-approved MDR 2a and FDA compliance, our platform slashes development costs. Seamlessly integrate innovative solutions and accelerate time-to-market. Join the future of digital health with myoncare.
No matter whether you need an advanced infrastructure for an existing solution or want to realize a new idea quickly and cost-effectively.1
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Class IIa medical device
ISO27001 & ISO 13485 certified QMS of ONCARE
No-Code Content Management System
Numerous features and automation options
Continuous further development since 2015
Hosted on servers in Germany
Already numerous successful projects
Interfaces to Withings, Apple Health and Google Fit
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Medical device software that previously belonged to Class I will, with a few exceptions, fall into at least Class IIa in future. This primarily affects software that is intended to provide information that is used to make decisions for diagnostic or therapeutic purposes.
Manufacturers must establish a quality management system certified in accordance with DIN EN ISO 13485.
Strict requirements apply to clinical trials, market surveillance and incident reporting.
Detailed technical documentation is essential, including comprehensive safety and performance certificates.
Whether you want to design your own digital program from scratch or offer your patients digital support with minimal effort - we have the right solution.
Maximum flexibility for your project. Create and combine your own content and manage patients via the innovative dashboard.
Digital health with minimal effort. Integrate your patients into an existing health program from our partner myon.clinic.
Our team will discuss your project idea with you. Book your non-binding consultation appointment now!
We use Calendly as our appointment system provider which needs you to allow all the cookies and refresh the page or click here . (By clicking on the link you will be redirected to the external page Calendly.com).
myoncare is a CE-marked class IIa medical device.
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Rx only. Medical Device Data System. The FDA has recommended enforcement discretion for this device.
ONCARE's QMS is certified in accordance with ISO 27001: 2017 and ISO 13485: 2016.
myoncare is DSGVO and GDPR compliant.
1 With myoncare, you can only use digital treatment paths within the scope of theintended purpose of myoncare. For example, myoncare may not be used for emergencies. Please contact sales@myoncare.com to find out more about myoncare and the possibilities for your project solution. For patient monitoring and diagnostic support, myoncare may currently only be used by healthcare professionals. The respective user/doctor is responsible for the creation of the content. The indications and contra-indications of myoncare must be observed.
2 The use of brand labels or references on this webpage is for informational purposes only and does not imply endorsement, sponsorship, or affiliation with the respective brands.
