Certificate in Device Regulatory Affairs: Mastery
-- ViewingNowThe Certificate in Device Regulatory Affairs: Mastery course is a comprehensive program designed to empower learners with the necessary skills to thrive in the rapidly evolving medical device industry. This course is of paramount importance as it provides in-depth knowledge of regulatory affairs, a critical aspect of medical device development and commercialization.
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โข Regulatory Affairs Overview
โข Medical Device Classification and Regulation
โข Global Regulatory Landscape
โข Regulatory Strategy and Compliance
โข Clinical Data and Regulatory Submissions
โข Labeling, Post-Market Surveillance, and Quality Systems
โข Regulatory Affairs for Software as a Medical Device (SaMD)
โข Regulatory Affairs in Mergers, Acquisitions, and Partnerships
โข Risk Management in Regulatory Affairs
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