MEDICAL DEVICE EXPERTS

Expert previously worked at FDA Center for Devices and Radiological Health (CDRH) in its Office of Device Evaluation for 8 years as a reviewer of 510k, PMA and IDE applications for cardiac medical devices (Rockville, MD). He reviewed all aspects of some of these submissions but the areas of his greatest specialization were electrical and mechanical testing and software development.
Device types include but are not limited to: cardiac, radiography, radiotherapy, non-ionizing imaging, urology, general surgery, neurology, ophthalmology, orthopedic, physical medicine, renal, gynecology devices, in vitro diagnostic products & imaging agents (considered to be drugs).
Expert has experience as an expert witness.


PhD physicist/chemist was an expert in radiologic devices at the FDA's Center for Devices and Radiological Health (CDRH) in the Office of In-Vitro Diagnostic Devices. In addition, he has extensive experience in radiation oncology.
At the FDA, lead or was a member of teams of engineers, medical officers and scientists who evaluated medical devices from bench-top testing to clinical evaluation to market approval.


Over 25 years at the FDA where he was a senior member of the staff at CDRH. The expert was a manager of medical device 510(k), IDE, and PMA evaluations, reengineering, standards, good manufacturing and quality system applications. He is a clinical regulatory scientist, and has extensive experience with clinical lab devices.   An MD clinical reviewer and medical officer at the FDA -Neuropharm. He reviewed antidepressants, antipsychotics, sedative-hypnotics, and anxiolytics. 6 years as researcher in the intramural program of the NIMH. Pfizer and Wyeth, which sell two of the drugs included in the study, declined to comment on the article. Both companies told the WSJ they had committed to disclose all of their study results, but not necessarily in medical journals.