Quality management

emka MEDICAL is an organisation with living quality management. At emka MEDICAL, the quality management system is strongly bonded to all areas of activities. Also, we can supply QM services to customers, including but not restricted to help in setting up your own quality management system.


We are regularly audited by the Notified Body MedCert (0482) according to EU laws.

Of course we can provide you with our certificates:

ISO 13485:2016 (pending) DE PDF
Annex II (pending) DE PDF
ISO 13485:2016 (pending) EN PDF
Annex II (pending) EN PDF

Contact QM for further information.