Corgenix is an FDA-registered manufacturer of medical products, and has more than 20 years of experience working with regulatory bodies, including the U.S. Food and Drug Administration, European Competent Authorities, and Health Canada. All of our design and manufacturing processes and manufacturing facilities are compliant with FDA Quality System Regulations and are certified to ISO 13485. The Corgenix manufacturing facilities are registered with the FDA (registration number 1721937). We offer comprehensive regulatory support, including, but not limited to:

  • Regulatory strategy 
  • Predicate device identification 
  • Clinical Study Protocol design 
  • Analytical Studies Protocol Design 
  • Statistical analysis plans 
  • Device classification 
  • Technical writing 
  • IDE applications 
  • Pre-submission (PreSub) communication and meetings with FDA 
  • Other consultations with regulatory agencies 
  • Regulatory product submissions to FDA, including 510(k), de novo 510(k), and PMA. 
  • CE Technical File preparation and submission 
  • Canadian Medical Device Licensing 
  • Postmarket support