ElMindA is audited and certified annually to be in full compliance with EN ISO 13485:2012, an international standard which specifies requirements for a company wide quality management system for manufacturers of medical devices and related services.

BNATM  Analysis system complies with applicable medical device regulations in the United States,  the EU, Brazil and Israel.

EN ISO 13485:2012 certificate (Valid to March 2019)

Israeli Ministry of Health approval of registration as a Medical Device 

ANVISA N0. 80117580520

Back to top