Expertise in Regulatory Compliance - About us

Metecon Switzerland LLC, based in Bern, provides complete regulatory compliance for your medical devices or in vitro diagnostics (IVDs).

We ensure that the excellent technical quality of your medical devices and in vitro diagnostics (IVDs) is also reflected in your processes and documentation. The purpose of our services is to allow you to focus fully on your technological expertise, while we ensure that your processes and documentation make for straightforward and speedy market access.

Our holistic approach aims to reduce your liability risks and increase safety for your patients and users. We are committed to ensuring that your products meet the highest quality standards and comply with the most stringent regulatory requirements and standards.

Rely on Metecon as your trusted partner! Together, we ensure that we promote patient health through safe and effective medical devices and in vitro diagnostics (IVDs).

5 good reasons to choose Metecon

Knowledge and experience: Our more than 60 employees are highly qualified experts with experience in the areas of quality management, technical documentation, post-market surveillance, regulatory affairs, clinical affairs, software, and digitization. We have in-depth expertise and continuously keep up to date with the latest developments.

Complete service: Metecon offers 360° services in the field of documentation, placing on the market, and post-market surveillance. We accompany and support manufacturers of medical devices and in vitro diagnostics (IVDs) in all phases of the product life cycle - from development to market approval to post-market surveillance. We find customized solutions that are practical and appropriate to our client's individual needs.

Flexibility and Reliability: Each project team operates in a flexible and responsive manner. We work closely with our customers to implement their specific requirements in a timely manner. We see ourselves as enablers and development partners for our customers. All employees are permanent; only in this way can we offer the continuity, reliability, and quality from which our customers benefit most.

Long-term partnership: We strive for trustful cooperation in which we master challenges and achieve success together. Our goal is to build long-term relationships and accompany our customers throughout their product lifecycle.

Innovation and digitalization: We know about the opportunities of innovation and digital solutions in the area of regulatory compliance - and also what digitalization often fails at. Together, we will find your best path. With our Metecon DigiLab, we support our customers in selecting and implementing suitable digital solutions to optimize processes and make them more efficient.

We stand with you as a strategic partner and are reliably at your side to meet regulatory requirements and to place your medical devices/in vitro diagnostics (IVDs) safely and successfully on the market.

Connect with us now and let's find out together how we can support you!

Welcome to the world of Metecon

Since 1999, Metecon has been supporting our customers at our location in Mannheim (Germany) in the creation and updating of product files for medical devices and IVDs. We perform verification and validation processes, support you in all aspects of Clinical Affairs and Regulatory Affairs, and optimize your quality management processes. With Metecon Switzerland LLC, we are expanding our Representative Services EC-REP and PRRC to include CH-REP and will eventually be closer to our customers, the Swiss manufacturers of medical devices and IVDs.

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Since 2020 the CEyoo GmbH, a sister company of Metecon, has temporarily taken over the responsibility as a legal manufacturer for regulatory affairs processes of medical technology companies that require more efficient processing. CEyoo performs all regulatory tasks and duties of a manufacturer. This includes the efficient planning, execution and documentation of quality management and post-market surveillance as well as all associated liability risks.