Inspection Readiness

International Standards

  • ISO9001 Quality Management Systems
  • ISO13483 Medical Device
  • ISO14001 Environmental Impact
  • ISO1800 Occupational Health and Safety

US – FDA

  • 21CFR211 (Drugs)
  • 21CFR 600 (Biological Materials)
  • 21CFR 820 (Medical Devices and Diagnostic Tests)
  • 21CFR 57 (Good Laboratory Practices)