Medical technology is a strictly regulated industry with a multitude of regulations and certification requirements. Since 1995 MT Promedt Consulting GmbH, located in St. Ingbert, Germany, has been providing support for medicical device- and IVD manufactures with CE certification and international registrations. The aim is comprehensive consultation for fulfillment of the complex requirements of the medical device regulations and therefore a fast and cost-efficient access to international markets. The complete service for CE certification ranges from the product-related regulatory strategy to the preparation of all documentation to prove conformity with the requirements of European regulations The company supports the establishment of modern company-specific quality management systems according to EN ISO 13485 and accompanies the corresponding audits. EN ISO 13485:2016 certified, MT Promedt Consulting GmbH also provides services as European Authorised Representative (EAR) for non-European medical device manufacturers according to the European Medical Device Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746. The company also offers the services as UK Responsible Person (UKRP) via our subsidiary MT Promedt Consulting Ltd located in Oxford and the service as CH-REP in Switzerland.
Electromedical Equipment / Medical Technology | Services and Publications
