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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⢠Regulatory Affairs Overview
⢠Biomedical Device Regulations and Standards
⢠Quality Assurance in Biomedical Regulatory Affairs
⢠U.S. Food and Drug Administration (FDA) Regulations for Biomedical Devices
⢠European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
⢠Biomedical Device Classification and Risk Management
⢠Pre-market Submissions and Approval Processes
⢠Post-market Surveillance and Reporting
⢠Biomedical Regulatory Affairs for International Markets
⢠Ethics and Compliance in Biomedical Regulatory Affairs
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