About Metecon

We are the holistic service provider for regulatory market access. We offer a wide range of consulting and support services to our customers for the verification and validation as well as documentation and approval of their medical devices and IVDs.

Why we do what we do

Frequently, we experience successful manufacturers of high-quality medical devices and IVDs who see their notified body or other surveillance authorities not as a partner for developing ideal solutions together but rather as a threat. This is why we want to put you, the manufacturer, in the position to communicate on a par with notified bodies and authorities as well as with users and patients.

With our services, we want to contribute that the extraordinary technical quality of your medical devices and in vitro diagnostics is also reflected in your processes and documentation.

We see it as our success if our customers can focus on their engineering competence and if their processes and documentation allow for uncomplicated, quick market access. The fact that we reduce the risks of liability for you as the manufacturer and increase the safety for patients and users is a welcome side effect we aim at.

Our customers are strong when
it comes to development. We know how to test, document
and launch medical devices efficiently. The result is a
quick and safe development process.
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Certificate

From the beginning, valued, long-term customer relationships have been more important to us than short-term profit. And we will keep it that way.
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How we work

We are experts in all those areas where our customers have insufficient capacities to manage and/or would have to gain new skills and abilities. This is how we solve shortfalls on manufacturer side or prevent them right from the beginning.

We understand ourselves as process supervisor, enabler, and development partner for our customers. Our team includes specialists experienced in various fields for hardware and software development, study and test planning, documentation, clinical affairs, QM, and regulatory affairs. All colleagues are employed on a permanent basis, because only then are we able to provide the quality, continuity, and reliability that will really benefit our customers.