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Biomedical Experts in Illinois
See more Biomedical Expert WitnessesThis highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.
Consultant, A private consultancy for FDA regulated businesses in IL
Bachelor of Arts (BA), California State University
East Alton |
Illinois
This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.
Industry Consultant, An FDA consulting corporation
Bachelor of Arts (BA), California State University
East Alton |
Illinois
This highly qualified expert earned his B.S. and M.S. in Mechanical Engineering and a Ph.D. in Biomedical Engineering from Marquette University. From 1977 until 2010, he held increasingly senior roles within Baxter Healthcare Corporation, most recently serving as the Technical Director of Applied Science & Technology. He was an Adjunct Professor at Northwestern University and spent four years at Exponent before becoming an independent consultant. The expert is a registered Professional Engineer in Illinois and has received 17 U.S. patents.
President, An engineering firm in IL
Doctor of Philosophy (PhD), Marquette University
Illinois
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FAQs for Biomedical Expert Witnesses
What is a biomedical expert witness?
A biomedical expert witness is a professional with extensive knowledge in the field of biomedical science. They provide testimony or informed opinions in legal cases involving medical devices, pharmaceuticals, and healthcare technology.
In what types of cases can a biomedical expert witness be beneficial?
Biomedical expert witnesses are crucial in cases involving medical device failures, patent disputes, pharmaceutical litigation, personal injury claims related to medical equipment, and more.
What subspecialties exist within the field of biomedical expertise?
Subspecialties include biomechanics, biomaterials, bioinformatics, medical imaging, genetic engineering, and regenerative medicine. Each has unique applications in legal proceedings.
How can a biomedical expert witness assist in a case involving medical device failure?
They can analyze the device's design, manufacturing process, and usage to determine if there were any flaws or negligence that could have led to its failure.
Why is it important for a biomedical expert witness to have experience with FDA regulations?
Understanding FDA regulations is key as they govern the approval and monitoring of medical devices and pharmaceuticals. This knowledge can help identify non-compliance or malpractice.
How does Expert Institute select its Biomedical expert witnesses?
Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.