Certificates

icoserve AIM is classified as a Class IIa medical device according to the European Medical Device Directive. This ensures that the optimal patient safety in the development of our products is always the top priority.

This is based on the maintenance and continuous improvement of our quality system according to EN ISO 9001:2000 and EN ISO 13485:2003, as well as our compliance with the regulations of the European Medical Device Directive.

Thus, the entire icoserve AIM fulfills all the legal national and Europe-wide requirements for medical devices.

Downloads:
EN ISO 9001:2000
EN ISO 13485:2003
CE Certificate according 93/42/EWG
Conformity declaration