Welcome to NCRG Mission Statement NCRG will use "best demonstrated practices" in providing sound clinical research, regulatory consultation, and quality system development to meet our customers' needs in a responsive, personalized, and professional manner. History Northwest Clinical Research Group, Inc. (NCRG) is a Clinical Research Organization (CRO) established in 2004 by Roberta Hines, President of NCRG. NCRG is a consulting firm with over 50 years of combined experience in regulatory affairs, clinical research and quality systems development. We currently employ five full-time employees and six contracted employees around the world.  We serve small medical device companies in, but not limited to, cardiovascular, endovascular, neurology, pulmonary, and orthopedic areas of healthcare. NCRG has extensive expertise with First In Man (FIM) studies around the world, IDEs within the US, and CE Mark studies in Europe.  Our experts have long-standing relationships with regulatory agencies and Notified Bodies to facilitate the US and CE Marking approval processes.  Location We are conveniently located just 20 minutes from downtown Seattle in Woodinville, Washington (just about 40 minutes from SeaTac Airport. We have the best of both worlds here in our offices which are situated in a beautiful, rural setting just a stepping stone away from the Cascade Mountain Range and the excellent wineries of Woodinville.  We invite our clients to visit us.

News Current Events for the Week of August 2nd, 2010:   Lawmaker Calls for Investigation Into Drug, Device Discrepancies Sen. Al Franken (D-Minn.) is asking the Government Accountability Office (GAO) to investigate why devicemakers don't receive the same incentives as drugmakers to create products for rare diseases. The request is in a letter sent July 21, the same day the Senate Health, Education, Labor and Pensions Committee held a hearing on treating rare and neglected pediatric diseases. "I'm concerned that we still don't have equivalent incentives for devices as we have for drugs," Franken said at the hearing. "I think we can do more." Devices & Diagnostics Letter   EC Updates Classification Guidance to Reflect Changes in the MDD Manufacturers should consider all of a device's characteristics when determining its classification in the EU, according to a new guidance. "The characteristic or combination of characteristics in accordance with the intended purpose of the device that rates the highest class determines the class for the device as a whole," the European Commission (EC) says in its revised MEDDEV 2.4/1 guidance on device classification. The new version takes into account changes in the Medical Device Directives (MDD). International Medical Device Regulatory Monitor   Zoll Monitor/Defibrillator Gets FDA Clearance Zoll Medical's Propaq monitor/defibrillator has received 510(k) clearance from the FDA. The device was designed for military customers and air medical operations, the company says. Zoll, Welch Allyn and the Department of Defense cooperated in the device's development, which was funded by grants from the U.S. Army Medical Research and Development Command. The device is smaller and lighter than other monitor/defibrillators, Zoll says, and offers a night vision mode.