Medical Devices Expert Witnesses

Medical Devices, Intellectual Property, & Polymer Chemistry Headshot
E-598360

Medical Devices, Intellectual Property, & Polymer Chemistry Expert

This Washington-based expert has over 20 years of experience in chemistry and medical device research, specializing in polymer synthesis, polymer characterization, analytical chemistry, medical device design and intellectual property management. He received his BES in chemistry and photographic sciences from St. Cloud State University before earning his PhD in polymer chemistry from the University of Southern California. He is active in his field as a member of the ...

Epidemiology, Nursing, and Medical Devices Headshot
E-663217

Epidemiology, Nursing, and Medical Devices Expert

This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in ...

FDA Regulation of Medical Devices Headshot
E-611415

FDA Regulation of Medical Devices Expert

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 American Society for Quality, and the FDA Alumni Association. Further, he ...

Medical Devices Headshot
E-377846

Medical Devices Expert

This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several ...

Medical Device Development Headshot
E-390825

Medical Device Development Expert

This expert has over 30 years of experience in medical device development, specifically cardiovascular devices. He earned his BS in chemical engineering from Arizona State University and is a member of the International Society for Endovascular Specialists. This expert has a high level of clinical expertise for surgical, vascular and endovascular devices and procedures and is well versed in implantable device failure investigation and evaluation. He previously served as ...

Medical Device Regulations Headshot
E-511302

Medical Device Regulations Expert

This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former ...

Medical Devices Headshot
E-099215

Medical Devices Expert

This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 ...

Medical Device & Consumer Products Engineering Headshot
E-160599

Medical Device & Consumer Products Engineering Expert

This highly qualified engineer earned his BS and MS in mechanical engineering from California Polytechnic State University. He went on to earn his PhD in mechanical engineering from the University of California, Berkeley. He has over 10 years of experience conducting failure analysis for various products including biomedical devices. He formerly served as Principal Mechanical Engineer at COR Innovations, Inc., a biomedical device start-up. In this role, he was ...

Medical Devices, Electric Shock Headshot
E-026336

Medical Devices, Electric Shock Expert

This qualified electric shock expert obtained his BS and MS in Bioengineering and Engineering Science from Stanford University and his PhD in Biomedical Engineering from Duke University. He is a Certified Professional Engineer and is a member of multiple engineering and bioengineering associations. The expert has published 75+ articles on electric shock and medical devices. He is an Emeritus Professor of Biomedical Engineering at a top university in the South and remains ...

FDA Regulatory Affairs & Medical Devices Headshot
E-053014

FDA Regulatory Affairs & Medical Devices Expert

This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. ...

Medical Devices & Bioengineering and Regulatory Affairs Headshot
E-032781

Medical Devices & Bioengineering and Regulatory Affairs Expert

This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and Medicaid Services, and other regulatory agencies around the world. As an ...

Medical Devices and FDA Headshot
E-007962

Medical Devices and FDA Expert

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications....

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