Elité Medica has made every effort to source referenced material from health professionals. 
Elite Medica operates to the applicable standards of the European Medical Device Directive (EU93/42) and has implemented a quality system in compliance with the applicable requirements of ISO:

UNI EN ISO 9001:2008 and UNI EN ISO 13485:2012


CE476 9001-2008 13485
  The EC
Quality Assurance System certificate
The ISO Certificates of the Quality Management System