Product Certification

Manufacturers may have difficulties in preparing technical documentation in accordance with the legal provisions of the country concerned. Local registration of the medical devices in various countries is sometimes the main barrier for international sales and marketing.

Experts of the ConsulTeam Medical can help you for preparation of technical documentation in accordance with relevant legal requirements, MDR (EU 2017/745) , IVDR (EU 2017/746), Medical Device Directives (93/42 / EEC, 90/385 / EEC, 98/79 / EC)) , USA (FDA 510 K), South American countries like Brazil, Mexico, Colombia together with Canada and Australia can be listed as the main countries within our expertise.