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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

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Class I, II and III Devices

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Substantial Equivalence Determinations

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Material Specifications

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Standard Test Methods

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Standard Test Guides

Clinical Trials

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FDA CDRH Compliance Master Planning and Strategy

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Risk Analysis

  • Efficacy Specifications

  • Performance Specifications

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