Natalie J. Kennel, RAC, ASQ CQE & CQMgr founded NJK & Associates to bring her practical perspective to medical device quality and regulatory affairs. With more than 24 years in industry, most devoted to medical devices, Kennel has hands-on experience with development and manufacturing as well as QA/RA and clinical roles in both major and start up medical device companies. She applies her expertise to the clinical and regulatory needs of medical device companies. Kennel has been published in RAPS regarding clinical trials for medical devices. She holds a BS degree in Chemical Engineering from the University of Rochester.