Gordon Harnack
About Gordon Harnack
Over 20 years device industry experience and 10 years as an independent regulatory consultant assisting FDA regulated firms with FDA compliance issues including PMA and 510(k) submissions, device master files, warning letter and FDA inspection issues, audits, training, Quality System development, management, design, production, document, purchasing controls, corrective and preventive actions, nonconforming product, Medical Device Reports, Reports of Corrections and Removals and Recalls. Led or assisted in dozens of submissions, including stand-along software submissions. Author of the 2nd Edition of "Mastering and Managing the FDA Maze - Medical Device Overview," published by ASQ's Quality Press, July 2014 – almost 500 pages! Available from ASQ @ http://asq.org/quality-press/display-item/?item=H1467 Make sure you are dealing with the 2nd Edition, ASQ has not removed the listing of the 1st Edition. Goals include leading or assisting with FDA submissions that are cost effective and are quickly reviewed by FDA and result in product distribution authorization; working with clients to resolve current FDA issues and developing cost effective strategies and programs that ensure compliance to appropriate FDA regulations; providing either short-term or long-term support that ensures appropriate regulatory compliance at reasonable cost. Specialties: presentations for national and international groups on FDA compliance, meeting with FDA to resolve issues, FDA medical device compliance, PMA and 510(k) submissions, Warning Letter and FDA Inspection responses, Quality System development, training, auditing [internal & supplier], ensuring FDA compliant component and stand-alone software, device master file(s), customer/client satisfaction surveys, and Official Correspondent and U.S. Agent for foreign firms regulated by FDA.