Masterclass Certificate in IVD Regulatory Affairs Compliance Essentials
-- ViewingNowThe Masterclass Certificate in IVD Regulatory Affairs Compliance Essentials is a comprehensive course that empowers learners with critical skills in the rapidly evolving In Vitro Diagnostic (IVD) industry. This certificate program highlights the importance of regulatory affairs compliance, an area of increasing significance due to growing regulations and enhanced quality standards.
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⢠IVD Regulations Overview
⢠IVD Classification and Exemptions
⢠Quality Management System for IVDs
⢠Design and Manufacturing Controls for IVDs
⢠IVD Labeling and Promotion Compliance
⢠IVD Clinical Evidence and Performance Evaluation
⢠Post-Market Surveillance and Vigilance for IVDs
⢠IVD Regulatory Submissions and Approvals
⢠Global Harmonization and International IVD Regulations
⢠Ensuring Compliance: IVD Regulatory Audits and Inspections
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