Our development - experts in innovation

As your partner, we take over the development of your medical product and guide it safely towards "time to market".

Our development process

Idea

Specification

Concept

Development

Admission

Idea

Whether you are a start-up, SME, corporation, university or inventor: we will listen to your concerns. In discussions with you and internally, we will advise you on whether and how your project is feasible (for us). Of course, you can also contact us at any time if your idea has already grown into something more.

Specification

We create the specification based on your risk analysis - the first and most important step in product development. With the proof of concept, we clarify whether the concept is practicable.

Concept

At the start, we're already thinking about the final. That's why we are also happy to advise you on market and approval requirements as part of the implementation concept. In the system architecture, we work out what your medical device is made up of and how these components interact.

Development

We develop and implement the hardware and software in various stages up to the prototype. During this process, we also take care of the technical documentation and verification to give your product the right regulatory framework. We conclude each development phase with a review to check the results.

Admission

Design, mechanics, hardware and software become a complete system. We verify the result, taking documented changes into account. We are happy to support you with the acceptance tests to validate the requirements and advise you on the subject of approval for procedures such as CE, CB, 510(k), PMA, De Novo, FDA and others.

Our development areas

Your advantages with us

We are flexible and like to think outside the box – this is how the most innovative projects are created.

André Coenen, M.Sc.

Director Development, Prokurist
Contact us