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 Finished Goods
Daily Order Processing
Customer Service
Turn-key Operations Management
On-site Guidance
Product Manufacturing
Electromechanical Assembly and Test
Disposable Assembly and Packaging
Material Procurement
Inventory Management