Biomedical Expert Witnesses

ID: 17817

This expert has over 20 years of experience in mechanical engineering, focusing on cryobiology. He earned his BS from the University of Madras, and his MS and PhD in mechanical engineering from the University of Colorado Boulder and the University of Minnesota, respectively. He has developed multiple courses related to biological thermodynamics and developed the bio-manufacturing and design lab...

E-695326

New Jersey

This expert has over 30 years of experience in the medical device industry, with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, heart assist devices, brain and aortic aneurysm treatment, and vascular closure products. He earned his MS in mechanical engineering at Moscow State Technical University and worked as the lead engineer at the Scientific...

ID: 18420

Massachusetts

This highly-qualified expert in cardiology received his MD from the University of Toronto. He then went on to complete an internship and residency in internal medicine at the Newton-Wellesley Hospital. This expert also completed a fellowship in cardiovascular disease at St. Elizabeth’s Medical Center of Boston and another in cardiac electrophysiology at Tufts Medical Center. He is also a member...

E-675156

Oregon

This highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early...

ID: 18664

This expert has over 30 years of experience in mechanical engineering, with a focus on developing new techniques, protocols, and instruments for long-term cryopreservation of human tissues. He is widely considered a world leader in cryobiomedical engineering with applications in cryopreservation, regenerative medicine, gene and cell therapy, bio-instruments, artificial organs, and organ...

E-007585

Maryland

This expert has over 40 years of experience as a mechanical engineer. His research in tribology, machining of advanced materials, medical device design, dental materials, and high temperature coatings is widely recognized in the scientific and engineering communities. He has published over two hundred fifty papers and reports related to machining of ceramics, mechanisms and mechanics of...

ID: 2148508

North Carolina

Dr. David T. Durack has over 49 years of experience in the field of Infectious Disease with additional expertise in the Medical Device and Diagnostic Industry. He earned his MBBS from the University of Western Australia School of Medicine and his Ph.D. in Experimental Medicine from the University of Oxford. He completed his residency in Internal Medicine and his fellowship in Infectious Diseases...

E-007664

Minnesota

This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently...

ID: 28022

Massachusetts

This highly qualified expert has over 30 years of experience in the medical device services and supply industry. He earned his bachelor's of science in electrical and clinical engineering from Northeastern University. He then went on to work in the clinical engineering department as a supervisor at Tufts New England Medical Center, where he oversaw the clinical department's equipment needs. He...

E-007962

California

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...

ID: 46128

Kansas

This expert specializes in pacemaker devices and has 30 years of experience in the healthcare industry. He earned his BSN from Wichita State University and his MHA from the University of Kansas. He is a Licensed Registered Nurse and is a Certified Cardiac Device Specialist. He has formerly served as a Staff Nurse at Olathe Medical Center, as Cardiovascular Data Manager at Shawnee Mission Medical...

E-032781

Massachusetts

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...

ID: 518086

Maryland

Dr. Christine L. Brauer has 34 years of experience in Medical Devices and Healthcare Regulation & Compliance. She earned her BA in Biology from the University of Delaware, her MS in Microbiology and Molecular Biology from the University of Virginia, and her PhD in Women's Health and Research Methods from the University of Maryland, College Park. Formerly, this expert served as the Vice President...

E-053014

Connecticut

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...

ID: 6743128

Maryland

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District Columbia

Mr. Steven D. Silverman has 31 years of experience in Healthcare Regulatory and Compliance. He earned his BA from the University of Michigan and his JD from the University of Pennsylvania Carey Law School. Today, this expert is licensed as an Admission to Practice Law in the District of Columbia. Formerly, this expert served as the Director of the Center for Devices and Radiological Health of the...

E-026336

Louisiana

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...

ID: 14943

Michigan

This expert has over 15 years of experience in progressive engineering, operations, and project management leadership in the highly regulated automotive, medical device & food manufacturing industries. He was a senior continuous improvement engineer for American Medical Systems, where he managed CAP and various engineering projects to improve system compliance for FDA class III medical devices....

E-160599

Oregon

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...

ID: 28245

Pennsylvania

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...

E-099215

New Hampshire

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),...