OMEDtech

OMEDtech, LLC is a medical device advisory firm and ISO 13485 certified contract manufacturer which partners with entrepreneurs, emerging medical device companies and investment firms to bring new products to the market. We provide the following services:

Regulatory Compliance Assistance
 IDE, 510K, PMA, HDE Submissions
 QSR (GMP)
 ISO13485, 11135

Clinical Trial Development and Management
 Protocol development
 Site Selection
 Monitoring

Quality Systems Development
 Quality Manual
 Policy Documents
 Procedures and Forms
 Implementation

Engineering Design and Test Services
 Environmental
 Heat Aging

Sterilization Validation Assistance
 Protocols/Reports

Order Fulfillment
 Warehousing of Fin...