EW #670 Ph.D. qualified as an expert for medical devices and technology. Ph.D. in Biomedical Engineering, Licensed Engineer and Certified Clinical Engineer. University affliation. Hospital and medical device related standards for training, use, and maintenance. Have served as an expert to the FDA regarding medical device issues. See website at www.bhbi.com for more information.
Founder and Director of a hospital biomedical engineering program for a 700+ bed acute care hospital system. Biomedical engineering staff member of Harvard Medical Center assigned to the King Faisal University Medical College and associated 500 bed teaching hospital. Biomedical engineering expert on behalf of ECRI to provide consultation services to hospitals nationwide. Provided independent expert biomedical engineering consulting to law firms, hospitals, medical device firms, and the FDA for over 25 years. Medical device expert on over 150 cases (60% defense and 40% plaintiff).
Expertise:
Biomedical Engineering, Clinical Engineering, Medical Device Design and Labeling, User Education and User Competence, Medical Technology Codes and Standards, Healthcare Organization Medical Technology Standards, and FDA Compliance.
Services:
Consultant for Attorneys/Law Firms, Healthcare Organizations, Medical Device Companies, the Federal Food and Drug Administration, and Insurance Companies. Expert Medical Device Forensic Investigations including deposition and expert testimony.
Professional Experience:
Founder and Director of a hospital biomedical engineering program for a 700+ bed acute care hospital system. Biomedical engineering staff member of Harvard Medical Center assigned to the King Faisal University Medical College and associated 500 bed teaching hospital. Biomedical engineering expert on behalf of ECRI to provide consultation services to hospitals nationwide. Provided independent expert biomedical engineering consulting to law firms, hospitals, medical device firms, and the FDA for over 25 years. Medical device expert on over 150 cases (60% defense and 40% plaintiff).
Education / Training:
Ph.D. Biomedical Engineering, University of Wyoming, Laramie, WY, 1972
M.S. Physics, Michigan Technological University, Houghton, MI, 1967
B.S. Applied Physics, Michigan Technological University, Houghton, MI, 1964
Professional Qualifications:
Registered Engineer - State of Michigan, status - current
Registered Electrical Engineer - State of California, status - current
Registered Safety Engineer - State of California, status - current
Certified Clinical Engineer in 1977
Professional Affiliations:
AAMI - Association for the Advancement of Medical Instrumentation
Other affiliations on request.
Publications:
"Recommended Standards for a Medical Equipment Management Program"
American National Standard, ANSI/AAMI EQ56: 1999. on AAMI Medical Equipment Management Committee and contributing author. Other publications on request.
Teaching:
1992-Present: Adjunct Professor and Advisor for the Biomedical Engineering Program at Michigan Technological University, Houghton, MI.
1984-86: Biomedical Engineer faculty, Harvard Medical College, Boston, MA.
1971-84: Adjunct Professor in M.S. Biomedical Engineering Program at California State University, Sacramento, CA.
Resources: Laboratories, hospital resources, and medical device test equipment available locally and through Michigan Technological University, Houghton, MI.
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