Regulatory Affairs Planning and Management

A required course in the Regulatory Affairs & Compliance for Medical Devices Certificate Program.

Learn how to organize your medical product design teams to meet the stringent FDA requirements and Regulatory Affairs. This course has two phases, concept review and evaluation review that provides a baseline knowledge on the role of regulatory affairs professional. Participants learn how to guide medical product designers through the design and development stages based on product classification to demonstrate safety and efficacy or performance for human use; and regulatory approval. Participants will be guided on how to conduct pre-submission meetings with the FDA, how to request meetings with the FDA, prepare and send pre-IDE packets, and how to record and document meetings with the FDA.

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