TRAXN Consulting provides regulatory affairs services to the medical device industry, covering a wide range of companies, devices and submission types. From strategy through execution, TRAXN Consulting can help you get your product to market and keep it there.
- Regulatory strategy
- PMA, HDE, IDE, 510(k), QSubs
- CE Technical Files
- Change management, labeling, promotion, business procedures
- Class I - III devices
We have a pragmatic, collaborative approach to achieving regulatory approvals of medical devices. Our experience in the medical device industry spans over 25 years, including working with the FDA, EU notified bodies and other authorities, all classes of devices and a broad range of technology and therapy areas. Contact us to learn more about how TRAXN Consulting can move your regulatory work forward.