The Regulatory Support Department of GIMDx will assist international medical device and healthcare products companies with meeting the regulations required to market their products in the US. This is achieved by coordinating manufacturers, FDA, regulatory consultants, and contract research organizations to complete the regulatory approval process in the US. The strength of the regulatory support team at GIMDx lies in the understanding and knowledge of the regulatory requirements in the US and in China, subject matter expertise, and close communication with all aspects of the business relationship.
GIMDx is actively engaged in the 510(k) submission of the Improvacuter® Blood Collection System products. Improvacuter® products from Improve Medical are commercially available in many countries including the US. The product line includes blood collection tubes, needles, collection sets and accessories. The Improvacuter® Gel & Clot Activator Tube is 510(k) cleared and available for purchase. Several of the other most frequently used blood collection tubes are being prepared for regulatory submission in the second half of 2015.
Please inquire to learn more about Regulatory Support with GIMDx.