Illinois
This 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...
Specialties:
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...
Specialties:
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...
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.
Biomedical expert witnesses are crucial in cases involving medical device failures, patent disputes, pharmaceutical litigation, personal injury claims related to medical equipment, and more.
Subspecialties include biomechanics, biomaterials, bioinformatics, medical imaging, genetic engineering, and regenerative medicine. Each has unique applications in legal proceedings.
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.
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.
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.