top of page
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
bottom of page