The links below give access to a wealth of useful material. Regulatory requirements are however complex and the implications of non-compliance can be serious. MDTc can help guide you through the regulatory jungle - contact us to discuss your needs
The MDA is the oldest organisation of its kind in the world, having been established as a part of the NHS in 1948 and is now part of MHRA, the Medicines and Healthcare products Regulatory Agency. Its accumulated experience in the field of medical device standards and evaluation gives it a unique international status.
Europa is the portal site of the European Union. It provides up-to-date coverage of European Union affairs and essential information on European integration. Follow the link to access the Medical Devices Sector home page.
The FDA has over 9,000 employees, located in 167 U.S. cities. Among its staff, FDA has chemists, microbiologists, and other scientists, as well as investigators and inspectors who visit 16,000 facilities a year as part of their oversight of the businesses that FDA regulates. Visit the FDA Center for Devices and Radiological Health home page here.
MedilinkEast was formed in 1998 to stimulate growth in the medical technology sector by establishing effective and sustainable partnerships between customers (hospitals, clinicians etc.), innovators (Universities and research organisations) and suppliers (companies providing medical equipment) in the East of England.
Clinical Solutions International
CSI is MDTc's strategic partner for clinical work in North America. CSI provides full service medical device brokerage. The team is experienced and strives to provide the best possible service as regards market entry.