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, market monitoring and in the optimization of your quality management processes.

Our services for your medical device

In vitro diagnostics

In vitro diagnostics (IVD) are 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 also 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 market monitoring (performance evaluation, clinical performance studies, PMS and PMPF) and in the optimization of your quality management processes.

Our services for your IVD

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.

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.

Why us?

Our team is your 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 project and any topic, so that you can continue to safely meet the regulatory requirements of the market.

Learn more about us

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