Illinois
Ms. Anne C. Mathias has 19 years of experience in Engineering and Mechanics. She earned her BS in Mechanical Engineering from the University of Notre Dame, her MSE in Mechanical Engineering, and her MS in Biomedical Engineering from the University of Michigan. Today, this expert is certified as an Ergonomics Assessment Specialist by The Back School of Atlanta and licensed as a Professional...
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:
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A medical device expert witness provides specialized knowledge about the design, manufacturing, and usage of medical devices. They can testify on issues like product defects, patent infringement, or improper use.
Cases involving personal injury due to defective devices, malpractice claims related to incorrect device usage, patent disputes, and regulatory compliance issues often require a medical device expert witness.
They can provide insight into whether the device was designed or manufactured properly, if it met industry standards, and if instructions for use were clear and accurate.
Yes, experts may specialize in specific types of devices such as orthopedic implants, cardiovascular devices, diagnostic equipment, or prosthetics.
An expert familiar with FDA regulations can provide crucial testimony on whether a device met regulatory standards and if any violations could have contributed to harm.
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