Mechatronic

We provide the development & manufacturing of your medical devices

In medical engineering, it can be a long way from the initial concept to a ready-to-market serial device. For this reason, our engineers at Mechatronic not only keep an eye on medical device development, but also constantly optimize 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.

High regulatory and documentation requirements apply to medical device manufacturers when manufacturing medical and in vitro diagnostic devices. With us, you get everything from a single source and at the highest quality standard: After development, we transfer your medical product directly to our production facility in Germany. From there, we deliver devices all over the world. Needless to say, we fulfill all requirements of the standards and directives ISO 13485, ISO 9001, FDA, CSA, CCC, Anvisa, UL and VdS. 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.

  • Are you looking for a partner to provide both medical device development and manufacturing services for your medical device?

  • Until now, you have had your medical products manufactured in another country, but now you want to transfer your production to Germany?

  • Are you asking yourself whether your idea can be implemented as a medical device at all and, if so, whether it can be realized within the prescribed budget? Through our pre-development we will figure it out for you.

  • Are you looking for a partner to provide both medical device development and manufacturing services for your medical device?

  • Until now, you have had your medical products manufactured in another country, but now you want to transfer your production to Germany?

  • Are you asking yourself whether your idea can be implemented as a medical device at all and, if so, whether it can be realized within the prescribed budget? Through our pre-development we will figure it out for you.

Our services for your success

We manufacture your medical devices according to ISO 13485 fast and safe in Germany

Is your ISO 13485 certified manufacturing affected by legal or political changes abroad? Together with you, we bring manufacturing back to Germany to our production facility – you benefit from secure supply chains, short delivery routes and the highest quality standards, among other things.

Our testing and certification procedures guarantee a safe and market-ready medical device

For us, testing does not begin when the medical device has been manufactured. From the very beginning, we ensure that all aspects of device development are covered via automated testing. Our test strategies include performance, stress or regression tests – because only in this way can we 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. In exchange with you, we evaluate the technical and industrial feasibility of your idea. In this way, you receive answers to your questions in a quick and easy way and we also keep an overview of the costs – you will know immediately after our checks whether the development and production of your medical device is within the predefined budget.

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