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 Certification
MAICO Diagnostics GmbH is certified to the requirements of ISO 13485:2016.
Medical CE-Mark
The CE-mark indicates that MAICO Diagnostics GmbH meets the requirements pursuant to Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III. Approval is made by TÜV SÜD identification No. 0123.
MDSAP Certification
MAICO Diagnostics GmbH is certified to the requirements of the Medical Device Single Audit Program (MDSAP).
