Certificate for software and processing
Computer konkret undertook varied efforts to improve the quality of the software and the satisfaction of our clients. Our quality assurance system was recertified by DEKRA Certification under EN ISO 9001.

Furthermore our company completed a challenging check according EN ISO 13485. This norm is based on EN ISO 9001 and follows the unique requirements for medical devices. In result of an extensive examination we obtained this certificate as well.

Our diagnostics software is in compliance with the Technical Documentation according to Annex II Section 3 of the Council Directive 93/42/EEC concerning medical devices of 14 June 1993.
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EN ISO 9001 / 12.2000 EN ISO 13485 / 07.2003 Annex II Section 3 of the Council Directive 93/42/EEC
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