TRAXN Consulting LLC

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.


If you have…

developed a new medical device, and now you want to get it cleared by FDA
just been called by FDA or your notified body and they will be inspecting or auditing your facility
just received a FDA-483 that you need to respond to in 15 days
a quality system that is managing you
compliance with ISO 13485, but you need to upgrade to 13485: 2016,
a large backlog of unresolved CAPAs or complaints that are putting your business in regulatory jeopardy

We can help […]