KAS Group helps companies navigate the increasingly complicated medical device environment that is regulated by the FDA and other government agencies. Whether your goal is to demonstrate substantial equivalence of a medical device through a 510(k) or implement an FDA or ISO13485 compliant quality system, a skilled KAS Group consultant can help. Below are some of the services that we offer:

Quality and Regulatory Compliance

FDA QSR, ISO13485 and more.

US Regulatory

Deivce Classification, 510(k), 513(g) and more

International Registration

Get your medical devices approved internationally.

European Union and CE Marking

Technical File, Design Dossiers, and Authorized Representative Assistance