Who we are and why we might be exactly the right choice for your business goals
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
(As defined in the Medical Devices Regulation (EU) 2017/745 (MDR), the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)) – from start-ups to established corporations throughout the world.
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
Our high quality compliance solutions include
- 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)
Team mdi Europa
Mr. Werner Sander
Quotes, contracts, general consultancy
Mr. Michael Sander
Special consultancy, authority contact person, technical documentation
Mr. Oliver Giesemann
General consultancy, free sales certificates, device registrations, quality manager
Ms. Astrid Schmiedtke
Ms. Ingrid Sander
Ms. Sheila O’Shaughnessy
In Memory Of
Mrs. Martina Sander-Giesemann
Co-founder of mdi Europa GmbH and Vice President Operation
*September 1974 – † June 2018
Mr. Michael Bain
Co-founder of mdi Europa GmbH and CEO
*November 1955 – † December 2009