With the experience of numerous FDA approvals on medical devices, our staff is well versed in all phases of CGMP implementation as well as PMA and 510k device submissions. This experience assures our clients of an accurate and expeditious process through the FDA maze, at a fraction of the cost of so-called "FDA Consultants."
- Design Verification/Validation Testing
- Clinical Study Protocols
- Quality Plans
- Quality System Implementation
- PMA & 510k Submissions