Medical Devices

  • FDA GXP compliance services
  • Medical Device Regulation (MDR) EU 2017/745 Compliance and Training Programs
  • In Vitro Diagnostic Regulation (IVDR) EU 2017/746 Compliance and Training Programs
  • CE Mark and International regulatory services
  • International product registrations
  • ISO 9001, 13485 and 14971, MDR and IVDR compliance
  • Quality systems development and training
  • Design dossier and technical file development
  • Project management services

 

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