Overview

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.

Our Expertise

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.

Services

Regulatory strategy
PMA, HDE, IDE, 510(k), QSubs
CE Technical Files
Change management, labeling, promotion, business procedures
Class I - III devices

TRAXN Consulting LLC

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