undefined   Medical Devices

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Spherix Consulting is a division of ChromaDex with a track record of success in navigating the development and regulatory landscape for medical devices. Our services include:

  • Regulatory filings
    • 501(k)
    • Investigational device exemption (IDE)
    • Pharmacology
    • Premarket approval (PMA)
      • Combination products
      • Master files
  • Scientific and regulatory due diligence
  • Class I, II and III devices
  • Substantial equivalence determinations
  • Material specifications
  • Standard test methods
  • Standard test guides
  • Risk analysis
    • Efficacy specifications
    • Performance specifications)
  • Clinical trials
  • FDA CDRH compliance master planning and strategy