This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.
B.S., University of Wisconsin
J.D., University of Wisconsin
Ph.D., University of Kansas
Former, Professor, University of Wisconsin Green Bay
Former, Senior Budget Planner UW System Administration,
Former, Senior Academic Planner UW System Administration
Former, Vice President for Academic Affairs, Drake University
Former, Vice President for Academic Affairs, Kennesaw State University
Former, Visiting Professor of International Studies, Georgia Tech
Former, Research Grants Development Administrator, Georgia Tech Research Institute
Former, Senior Consultant, Excel Partnership, Inc.
Former, Senior Consultant, SAI Global
Current, Legal Consultant and President, international standards and regulations consulting firm