Quality Management

At IMAGE Information Systems, we ensure compliance with legal and regulatory requirements by having implemented an effective quality management system that is continuously reviewed and optimized.

Our quality system complies with regulatory requirements according to DIN EN ISO 13485 and 21 CFR part 820 (FDA).

Certificate of Conformity_13485 EN 2021-02-22
Certificate of Conformity_93.42.EEC EN 2021-05-04