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