Certificate in Regulatory Affairs for In Vitro Diagnostics
-- ViewingNowThe Certificate in Regulatory Affairs for In Vitro Diagnostics is a comprehensive course designed to meet the growing industry demand for experts in this field. This program emphasizes the importance of regulatory compliance in the In Vitro Diagnostics (IVD) industry, a critical aspect of medical device development and manufacturing.
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โข Regulatory Foundations for In Vitro Diagnostics
โข IVD Classification and Regulation in Major Markets
โข Quality System Management for IVDs
โข IVD Labeling, Advertising, and Promotion Compliance
โข IVD Clinical Evidence and Performance Evaluation
โข Post-Market Surveillance and Vigilance for IVDs
โข IVD Submissions and Approvals Process
โข International Harmonization and Standards in IVD Regulation
โข Ethical Considerations in IVD Regulatory Affairs
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