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 doFrequently, 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.
How we workWe 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.
- 1999 The Metecon founders Alexander Fink and Ulrike Kamecke establish metecon Ingenieurbüro Kamecke & Fink GbR. From then they develop functional models and prototypes for medical engineering.
- 2003 Conversion into Metecon GmbH.
- 2005 New strategy: We become experts for documentation, verification, and market access.
- 2006 DIN 9001 and DIN 13485 determine our work process; Metecon then employs eight engineers.
- 2011 More space for everybody: From Stadthaus N1 we move to the Water Tower with lots of space for growth and new ideas.
- 2015 Companies must create benefits – not only for their customers but also for their employees: Metecon takes first steps towards participation and self-organization. Ulrike Kamecke leaves the management.
- 2016 We abandon hierarchies and the organizational chart is turned upside down: Middle management doesn’t exist at Metecon; we strengthen and develop the talents and abilities of each individual; colleagues with special responsibilities serve their fellow colleagues.
- 2017 With the MDR, our work gains momentum and significance: Manufacturers have to be sensitized, texts interpreted, deadlines met. And we can prove that we live up to our name as a “strategic partner”.
- 2018 Metecon wins the TOP JOB employer competition and is awarded the title “Employer of the year 2018”; in addition, as one out of four companies, we are awarded the special title “Top employer 2018 focus women”.