If you are a medical device importer, manufacturer or inventor,
I can answer your questions concerning the FDA requirements for introducing a new device into commerce. If you are physician planning to test a new medical device using human subjects, I can explain the rules for an investigational device exemption. If you want someone to prepare the necessay paperwork for you, I am affiliated with a full-service organization that can do the job for you. I specialize in the evaluation of the devices used in neurosurgery, neurology, and psychiatry.
I have more than twenty years' experience in device evaluation. My doctorate is in biomedical engineering from the University of Virginia, and I am post doctoral fellow of the Johns Hopkins University School of Medicine.
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