Manufacturing & Assembly

Our Irvine, California facility is structured to complete component processing, final assembly, packaging and distribution activities for our ClearPoint® system, as well as support our design, development and prototyping activities for the ClearTrace® system. The assembly process is performed in a controlled environment as required by applicable regulation for medical device assembly. Our operations are subject to regulation by the FDA under its Quality System Regulation.  Our Irvine, California facility is FDA-registered.  We are also certified to ISO standard 13485.

 DEKRA logo - ISO 13485:2003