ecm's service spectrum
ecm's services encompass the performance of conformity assessment procedures in accordance with Directives 93/42/EU and the certification of quality management systems according to DIN EN ISO 13485 and related standards, such as EN ISO 9001 or EN ISO 15378. ecm belongs to the small circle of Notified Bodies, which are permitted to provide, for the manufacturers of medical devices, the prescribed assessments for acquiring certificates for the European market.
An obligation on the one hand, an option on the other.
We will quickly find out in a dialogue whether you only need
CE-marking for your medical device or further certificates. ecm is the right partner for both processes. Useful information on both requirements is provided below.
The legal basis for a Notified Body is the authorization by the appropriate authority (in Germany, the Central Federal Agency for Health Protection in Pharmaceuticals and Medical Products (ZLG)). ecm has been notified by the European Commission for non-active medical devices.
All our services are provided primarily in the Health Care and Life Science sector.