We enable market access for medical devices and IVDs
Medical devicesMedical 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 diagnosticsIn 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 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.
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 the project and any topic so that you can meet the regulatory requirements of the market.Learn more about us
The latest news on regulatory compliance
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.Subscribe to our newsletter and use our free info service (sorry, only in German available)