Description : Certification of Quality Management Systems of Manufacturers of Medical Devices
The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove the conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device.
