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...
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 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:
A medical device expert witness is a professional with extensive knowledge and experience in the field of medical devices. They provide testimony or consultation in legal cases involving these devices.
Medical device experts can handle cases involving product liability, patent infringement, regulatory compliance, failure analysis, and personal injury related to medical devices.
Yes, some experts specialize in specific types of devices such as orthopedic implants, cardiovascular devices, diagnostic equipment, or surgical instruments.
They can analyze the design, manufacturing process, and usage instructions of the device to determine if any negligence occurred that could have led to harm or injury.
An expert in FDA regulations can provide insight into whether a device was compliant with all necessary rules and guidelines at the time of an incident.
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