Clinical Studies for Medical Devices
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Who Should Attend
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Description
This course will present detailed information on regulatory and operating issues which directly impact on the conduct of clinical studies for medical devices. Participants will gain knowledge and workshop experience in designing, implementing, and monitoring clinical studies. Discussions will include clinical protocol design and implementation for devices, monitoring requirements and procedures to assure protocol compliance, the biostatistician’s role in designing the study and writing the final report. Expanded bioethical considerations and pragmatic approaches to the selection, qualifications and responsibilities of the investigators will also be discussed. Emphasis will be placed on the special requirements of the Investigational Device Exemption (IDE) Regulations for domestic studies, but with consideration of global strategies.