Manufacturers of active medical devices intended to remain permanently in the body are only allowed to sell products on the European market if they comply with this directive.
DEKRA has been officially designated to review the compliance of products with the requirements of the AIMDD for access to the European market. We are also accredited to grant access to markets in other countries. Moreover, you can call on us for certification of your Quality Management System according to ISO 13485 and Directive 2007/70/EC, which became mandatory for medical device manufacturers in March 2010.
DEKRA is a full service provider for medical device manufacturers. Consider these advantages: