SPI USA, Inc., Amsterdam Marriott Hotel
November 6-7, 2006
SPI USA, in collaboration with CardioMed Device Consultants, offers a 2-day FDA Medical Devices Regulations & Approval Process training seminar. The course is taught by Dr. Semih Oktay, former scientific reviewer at the U.S. FDA and President and Founder of CardioMed Device Consultants, LLC.
The course will cover such topics as: Device Classification & Regulatory Requirements, the FDA Approval Process, Pre-market Notification & Aproval Applications, IDE's, Pre-clinical Studies, and Combination Products.
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