What does Metecon do?

Metecon is your strategic partner for regulatory resilience and market access for medical devices and in vitro diagnostic devices (IVDs). Our interdisciplinary team will accompany you throughout your product's entire life cycle – from development and approval to post-market surveillance – and secures sustainable structures for your company together with you.

With our in-depth knowledge of regulatory affairs, clinical affairs, quality management, technical documentation, verification, and validation, we ensure your products remain safe, compliant, and marketable. We also support the digitalization of regulatory processes, the use of AI-supported solutions, and PRRC and representative services (EC-REP and CH-REP).

As an equal partner, we think long-term, act pragmatically, and create structures that combine regulatory stability and competitiveness – today and in the future.

Certificates

Certificate DIN EN ISO 9001:2015 (English)
166 kB

Certificate DIN EN ISO 9001:2015 (German)
166 kB

Your regulatory resilience is our goal

Regulatory resilience is not just a buzzword for us; it's our commitment.

Every day, we witness manufacturers being held back by misinterpreted requirements, lengthy processes, and unclear communication. All too often, notified bodies are seen as hindrance, and regulatory requirements as obstacles rather than a framework for quality and safety. At Metecon, we aim to change that perception.

Our goal is to facilitate communication on equal terms and work strategically with the notified body.

We take care of communication with your notified body or are happy to conduct discussions together with you. In addition, we translate requirements into clear, actionable strategies and are committed to ensuring that regulation remains practical for you.

We refuse to accept that more and more good products are disappearing from the market simply because the hurdles are set too high.

For us, regulatory resilience means the following:

Acting with clarity and structure
Staying in dialogue with partners
Finding ways together that are safe, sensible, and feasible

We want your products' technical excellence to be reflected in your documentation, processes, and communication so you can focus on innovation for the benefit of patients and users.

Metecon – greater clarity, stability, and partnership-based solutions in regulatory affairs.

How we work

We are your partner for regulatory resilience, dialogue, and relief, especially when resources are scarce or new skills are needed.

Our team of experienced experts covers the entire spectrum of regulatory compliance, from regulatory and clinical affairs to quality management, the digitization of workflows, and AI-supported solutions, as well as PRRC and representative services (EC/CH REP).

We see ourselves as process facilitators, translators, and co-creators. We bring structure to complex processes, build trust with authorities and notified bodies, and help manufacturers not only meet regulatory requirements but also master them strategically.

This creates regulatory resilience that carries into the future and is sustainable.

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.

Documenting for medical technology “Risk-compliant and fast” - Metecon GmbH

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.