Medical devices and in vitro diagnostics (IVDs) can only be successfully and legally marketed if you, as a manufacturer, meet the regulatory requirements of the target market. These requirements are diverse and complex, and also include the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostics Regulation), as well as country-specific regulations.
From the development of new products, technical documentation according to MDR/IVDR, maintenance of existing medical devices/IVDs, verification and validation, market entry into new target markets, post-market surveillance (PMS and PMCF/PMPF) to the optimization of your quality management processes, Metecon provides you with the full range of compliance services to optimally support you throughout the entire product life cycle of your medical device/IVD.
With a team of over 60 regulatory compliance professionals, we have both breadth and depth. We assemble project teams according to our clients’ needs. Our size allows us to offer a wealth of expertise. Whatever expertise you need, we have it. There’s no such thing as “too small” or “too big” for us – our sole focus is to use our knowledge and experience to help medical device/IVD manufacturers enter the market and maintain existing certifications.
Get to know us – We look forward to meeting you!
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