We enable market access for medical devices and IVDs

Medical devices

Medical devices can only be marketed successfully and legally if you as a manufacturer meet the regulatory requirements of the target market. These requirements are diverse and complex with the MDR (Medical Device Regulation, EU regulation for medical devices) and other country-specific regulations.

With us, you get the full range of compliance services to support you optimally through the entire product lifecycle of your medical device: in the development of new products, in technical documentation according to MDR, in the maintenance of existing medical devices, in verification and validation, market entry into new target markets, post market surveillance and in the optimization of your quality management processes.

Our 360° service for your medical device

In vitro diagnostics

In vitro diagnostics (IVD) are the medical devices that are regulated in a separate regulation (In vitro diagnostic regulation, IVDR) due to their special nature. Safe and effective products should result from the efficient interaction of the various quality management processes and be maintained throughout the entire product life cycle.

Metecon advises and supports you on IVD regulatory compliance at all levels and at any point in the product life cycle in order to meet the requirements of the IVDR and other country-specific regulations: in the development of a new IVD, in the maintenance of existing IVDs, in market entry into new target markets, in post market surveillance (performance evaluation, clinical performance studies, PMS and PMPF) and in the optimization of your quality management processes.

Our services for your IVD

Register now: IVDR webinar in collaboration with BSI Group

How to Best Work with a Notified Body for an Efficient Transition

How to work with your Notified Body for an efficient transition to IVDR? On 20 March, we will provide you with actionable strategies and important insights:

Our guest speaker Charlotte Hess, Business Development Manager Regulatory Services for IVD at BSI, will present "The IVDR Application Process – What Do You Need to Know?".

Afterwards, Dr Sandra Reuter, Senior Expert IVD at Metecon, will share her experiences and tips on "IVDR Implementation – Lessons Learned & Best Practices" and show how you can make the most of the short IVDR transition period.

The webinar is free of charge, and is conducted in English.

More information on the webinar

More than 20 years of experience in regulatory compliance

Metecon GmbH is one of the pioneers in Germany when it comes to standard- and guideline-compliant consulting and support for medical device manufacturers and manufacturers of IVDs: Since 1999, we have 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, and in the optimization of quality management processes.

What our client say about us

Our customers are startups, SMEs and corporations. We put together project teams according to our customers' needs; due to the size of our company, we can draw from a wide range of resources: no matter what expertise you need, we are ideally positioned.

For us, there is no such thing as "too small" or "too big" - we see manufacturers of medical devices and IVDs that we can help to enter the market and maintain existing certificates with our know-how and experience.

All the nicer when a business relationship grows into a real partnership. We thank our customers for their kind words and are very happy to work with them and other great people on exciting projects.


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Compliance requires in-depth and comprehensive knowledge. Our newsletter conveys both: sent out at regular intervals, it provides you with best practices from our experts in documentation, market access and market monitoring, information on current events, topic overviews and tips for your implementation - in short: our newsletter keeps you updated.

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Why us?

Our team is reliable partner when it comes to documentation, verification, validation, market access, and market surveillance (PMS, PMCF/PMPF) of your medical device or IVD. Capacity bottlenecks are passé with Metecon; we support you sometimes selectively, sometimes over a longer distance, but always reliably and solution-oriented. We are growing continuously so that we can serve your request flexibly and quickly.

Our more than 50 experts in the respective fields are all engineers and scientists. This allows us to quickly provide you with the best support for any size of the project and any topic so that you can meet the regulatory requirements of the market.

Learn more about us

Our services at a glance

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