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About TRAXN Consulting LLC

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

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Leadership

The top of TRAXN Consulting LLC's org chart, with how many people report into each leader.

MJPhoto of Marianne Jacklyn

Marianne Jacklyn

President & Principal Consultant

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