Regulatory & Certifications

iso-cert

 

MBL BION is compliant with the following regulatory processes:

 

  • FDA regulated
  • Good manufacturing practices are followed in all production processes
  • ISO 13485 Certified
  • CMDR under CMDCAS (Canadian Medical Devices Conformity Assessment System)
  • CE Marking
    Authorized Representative
    QARAD BVBA
    Cipalstraat 3
    B-2440 Geel
    Belgium