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