We provide the development & manufacturing of your medical devices
It can be a long road in medical technology from the initial concept to a marketable series device.
For this reason, our engineers at Mechatronic not only keep an eye on the development of medical devices, but also constantly optimize the development processes. Whether it is software or electronics development, mechanical designs, verification work or sub-projects in component development – through our networking, with YOOme you are relying on a competent partner.
The production of medical and in-vitro diagnostic devices is subject to stringent regulatory and documentary requirements for medical device manufacturers. With us, you receive everything from a single source and to the highest quality standards: we transfer your medical device directly to our production site in Germany after development. From there, we deliver devices all over the world. It goes without saying that we meet all the requirements of the standards and guidelines ISO 13485, ISO 9001, FDA, CSA, CCC, Anvisa, UL and VdS, and regular audits confirm our compliance.
At our production site in Höhn in the Westerwald region of Germany, we fulfill all requirements of the standards and directives ISO 13485, ISO 9001, FDA, CSA, CCC, Anvisa, UL and VdS.
Our services for your success
We manufacture your medical devices according to ISO 13485 fast and safe in Germany
Is your ISO 13485-certified production affected by legal or political changes abroad?
We will work with you to bring production back to our manufacturing site in Germany – you will benefit from secure supply chains, short delivery routes and the highest quality standards.
Our testing and certification procedures guarantee a safe and market-ready medical device
For us, testing does not just begin once the medical device has been manufactured.
Right from the start, we ensure that all aspects of device development are covered by automated tests.
Our test strategies include performance, stress and regression tests – because this is the only way we can develop and manufacture a safe and market-ready medical device for you.
Our automated testing also increases efficiency in the development process, as we drive development during the day while automating testing overnight.
With our pre-development we check your idea for feasibility
Our engineers focus on solutions.
We work with you to evaluate the technical and industrial feasibility of your idea.
This provides you with quick and uncomplicated answers to your questions, and we also keep an overview of the costs – after our tests, you will know directly whether the development and production of your medical device is within the previously defined price range.
An overview of all services for your medical device
Proof of Concept
Feasibility study
System and security concept
Technical risk analysis
System development
Device development
Technical risk management
Testing
Transfer to production
Serial production
