Certification

As a manufacturer of medical equipment, MAICO is certified in terms of ISO 13485:2016, the Medical CE-Mark and the Medical Device Single Audit Program (MDSAP). You will find the corresponding documents below.

  • iso_13485_2016_maico

    MAICO Diagnostics GmbH is certified to the requirements of ISO 13485:2016.



  • tv-ec-certificate

    The CE-mark indicates that MAICO Diagnostics GmbH meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval is made by TÜV identification No. 0123.



  • maico_mdsap_certificate

    MAICO Diagnostics GmbH is certified to the requirements of the Medical Device Single Audit Program (MDSAP).