Professional Certificate in Biomedical Regulatory Affairs for Quality Assurance
-- ViewingNowThe Professional Certificate in Biomedical Regulatory Affairs for Quality Assurance is a comprehensive course designed to equip learners with the necessary skills to succeed in the rapidly growing biomedical industry. This program emphasizes the importance of regulatory compliance, quality assurance, and risk management in biomedical research, development, and production.
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โข Regulatory Affairs Overview
โข Biomedical Device Regulations and Standards
โข Quality Assurance in Biomedical Regulatory Affairs
โข U.S. Food and Drug Administration (FDA) Regulations for Biomedical Devices
โข European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
โข Biomedical Device Classification and Risk Management
โข Pre-market Submissions and Approval Processes
โข Post-market Surveillance and Reporting
โข Biomedical Regulatory Affairs for International Markets
โข Ethics and Compliance in Biomedical Regulatory Affairs
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