mdi Europa GmbH

mdi Europa GmbH was founded in March 2000 to provide medical device manufacturers world-wide with flexible and well-adjusted service packages to assist clients to comply with EU legislation. mdi Europa GmbH acts as European Authorized Representative for a wide range of companies from start-ups to established corporations throughout the world (As defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)). Our highly qualified regulatory affairs specialists provide hands-on experience. They have registered hundreds of medical device manufacturers for CE Marking with the European competent authorities. We exactly know the challenges and needs connected to small and medium-sized enterprises. Due to our lean structure, we not only safeguard flexibility and efficient pricing, but also continuing reliable guidance by one contact person throughout all processes. We have created a world-wide network of regulatory experts This enables us to provide our clients with excellent regulatory services around the world. If you want to find out more, your are welcome to read some words from our customers and network partners. Our customers are - manufacturers - importers - exporters - distributors Our high quality compliance solutions include - classification - identification of EU standards - Technical Documentation compilation and review - product registration to national EU authorities - labeling compliance - Free Sales Certificates - market research - translation services and more As confirmed by our ISO 9001:2015 certification.

• Employees 3
• Founded 2000