For CE-marking of active medical products the according tests are required. By means of a test it is validated, that defined requirements, e.g. specifications or regulatory standards, are implemented. Usually a test is executed by a test laboratory. Test results and test documents within the scope of CE-marking are part of a product documentation to document fulfilment of applicable essential requirements.

By testing for electrical safety of an active medical product it is proven, if security of patients, users, and third parties is provided and design and construction are according to general technical rules.

MEDCERT has a cooperation with CEcert Gmbh - a test laboratory for active medical products. All tests there are executed according to internationally established, and as far as published, harmonized standards.

For more information please visit www.cecert.com.