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".
As your partner, we take over the development of your medical product and guide it safely towards "time to market".
We develop innovative medical technology and medical devices with a focus on safety, regulatory compliance, and market success. As an ISO 13485-certified development service provider for medical technology, we take on the contract development of your medical products – from the initial idea to speicification and concept to approval.
BYTEC combines technological expertise, quality management, and regulatory affairs to create clearly structured development processes throughout the entire product life cycle.
Idea
Specification
Concept
Development
Admission
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.
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.
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.
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.
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.
When it comes to developing medical devices, it's not just technical expertise that counts, but also experience, reliability, and a sense of responsibility. We have over three decades of experience and carry out challenging projects in medical technology – with a deep understanding of regulatory, clinical, and technological requirements.
As an independent, family-run development service provider, we work in partnership with our customers on an equal footing. Together, we develop solutions that are technically convincing, regulatory compliant, and focus on users and patients.
We are flexible and like to think outside the box – this is how the most innovative projects are created.
André Coenen, M.Sc.
