Medical Devices

Spherix Consulting has 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
  • Clinical Trials
  • FDA CDRH Compliance Master Planning and Strategy
  • Risk Analysis
    • Efficacy Specifications
    • Performance Specifications