Certificates
Our customers are strong when it comes to development. We know how to test, document and launch medical devices and IVDs efficiently. The results are a
quick and safe throughout the development process.
quick and safe throughout the development process.
Purpose of Our Work
We regularly experience that successful manufacturers of medical devices and IVDs do not see their "notified bodies" and other surveillance authorities as partners with whom they strive for optimal solutions, but perceive them as threats. Therefore, we want to enable you, the manufacturers, to communicate with Notified Bodies and authorities as well as with users and patients on an equal footing.We want to make sure that the excellent technical quality of your medical devices and in-vitro diagnostics is also reflected in the processes and the documentation. We see it as our success if you can concentrate on your technical competence and your processes and documentation allow uncomplicated rapid market access. The fact that we also reduce your liability risks and increase safety for your patients and users is another desired effect.How We Work
We are experts in all those areas where our customers have insufficient capacities to manage 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 see ourselves as process supervisor, enabler, and development partner for our customers. Our team includes specialists experienced in all fields for documentation, clinical affairs, QM, and regulatory affairs. Our 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.
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.
The right offer for every challenge
You can build on our experience and know-how in Regulatory Compliance: Since 1999, Metecon has been a strategic partner for our customers in the creation and maintenance of product files for medical devices and IVDs, in the verification and validation of these products, for all aspects in the areas of clinical affairs and regulatory affairs, as well as in the optimization of quality management processes.With Metecon Switzerland, we now offer this proven service cycle to our Swiss customers on-site as well as to manufacturers of medical devices and IVDs looking to place their products on the Swiss market: Metecon Switzerland represents regulatory consultation and support in accordance with all relevant requirements, ensures manufacturers from the EU and other markets safe access to the Swiss market as a Swiss Authorized Representative (CH-REP).Efficient ideas and new perspectives - Get to know us!
CEyoo GmbH, a sister company of Metecon, temporarily takes on the role of Legal Manufacturer for medical technology companies that want, to handle their regulatory affairs processes more efficiently, i.e. CEyoo takes over the regulatory tasks and duties of a manufacturer. including efficient planning, execution and documentation of quality management and market monitoring as well as all associated liability risks.For non-EU manufacturers planning market access in European market, Ceyoo, acts as an EU Authorized Representative (European authorized representative, EU-REP/EC-REP), takes on the regulatory responsibilities in the EU in accordance with MDR/IVDR Art. 11.Wondering if CEyoo can make an economic difference for you? Let's find out!
History of Metecon until now
- 2024
We are pleased to announce the appointment of Katharina Thievessen to the Board of Directors! Thievessen has been an authorized signatory and responsible for the operational management of the company since 2020. She now leads the company together with founder and managing partner Alexander Fink. - 2023
The TOP JOB trophy is also coming to us again in 2023! The main reason why we now participate is the comprehensive survey, evaluation and concluding personal analysis, interpretation and advice: How do various aspects of decisive indicators such as employee satisfaction, motivation and leadership develop compared to previous years? What is going well, what can we improve and how? After all, TOP JOB is a nice award, but our benefit from the acquired insights is INCREDIBLE!
- 2021
Metecon is a Great Place to Work! What does that mean? The fact that our more than 50 colleagues agree that fairness, credibility, team spirit and trust play an important role in our corporate culture. Thank you very much for your trust! - 2020
From one day to the next in March, the office is suddenly closed. Thanks to our state-of-the-art IT, it's not an issue: Those who weren't already working partially mobile pick up their laptop, headset, and other equipment from the office, grab a monitor (or a second one) and an office chair, and seamlessly start working from home. We miss each other - to stay connected, we establish virtual routines.We are the TOP JOB award winners for the second time! The jury has given us excellent ratings for employee development and family-friendliness, and thus it confirmed that we all enjoy being successful entrepreneurs within the company. For us, this is a sign that we are on the right track. - 2018
Metecon is the winner of the TOP JOB employer competition and thereby "Employer of the Year 2018"; in addition, we are one of four companies to receive the special "Top Employer 2018 Focus Women" award.
- 2017
With the MDR, our work becomes more explosive and important: manufacturers have to be sensitized, texts interpreted, deadlines met. And we can prove that we live up to our name as a "strategic partner." - 2016
We do away with hierarchies and the organization chart is upside down: Middle management does not exist at our company; the talents and abilities of each individual are strengthened and promoted; those who bear special responsibility are at the service of their colleagues*. - 2015
Companies must create benefits - not only for customers, but also for employees: Metecon takes first steps towards participation and self-organization.
- 2011
More space for everyone: From townhouse N1, it's off to the water tower with plenty of room for growth and new ideas. - 2006
DIN 9001 and DIN 13485 determine our work process; Metecon employs eight engineers at this time. - 2005 Change of strategy:
We become experts in documentation, verification and market access.
- 2003
Change of name to Metecon GmbH. - 1999
Established metecon Ingenieurbüro Kamecke & Fink GbR for the development of functional samples and prototypes for medical technology.
