Regulatory Compliance

Compumedics continues to instill a culture of quality within all processes and employees, which is reiterated by a globally recognized quality assurance system. The Company’s rigorous quality assurance system addresses all medical and manufacturing regulatory requirements including:

  • FDA (USA)
  • CE Mark (Europe)
  • TGA (Australia)
  • IEC 601-1 patient safety standards
  • UL and CSA electrical standards
  • ISO 27001:2013 Information security management systems
  • ISO 13485 Quality Systems – Medical Devices
  • Good Manufacturing Practice (GMP)

Compumedics works closely with regulatory approval authorities, including: Therapeutic Goods Administration in Australia (TGA), Food and Drug Administration in the USA (FDA), CE Mark in Europe; the Korean Food and Drug Administration, and Japanese regulatory approval bodies. Compumedics believes that all its products currently in the market and their manufacturing processes meet the requirements of the appropriate regulations.