MT Promedt Consulting is an EN ISO 13485:2016 certified German consultancy for the healthcare industry (medical technology, in vitro diagnostics, biotechnology, pharmaceutical industry, therapeutic equipment). Our services range from assistance in the setup of quality assurance systems to preparation of CE certification and product registration. This includes also support in the preparation of product documentation, preparation and completion of product notification, and interaction with EU authorities.

For non-European manufacturers, we offer the qualified and professional service as an independent European Authorized Representative according to MDR/IVDR and as required by European regulations.

In addition, through our network, we meet the complex requirements for international product registration and thus facilitate quick access to different markets.