Advanced Certificate in MedTech Regulatory Frameworks: Global View
-- ViewingNowThe Advanced Certificate in MedTech Regulatory Frameworks: Global View is a comprehensive course designed to meet the growing industry demand for experts with a deep understanding of global MedTech regulatory frameworks. This certificate course emphasizes the importance of regulatory compliance in the MedTech industry and equips learners with essential skills for career advancement.
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โข Global MedTech Regulatory Landscape
โข Legal Basis for MedTech Regulations
โข International MedTech Regulatory Frameworks (IMDRF)
โข European Union (EU) Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)
โข United States (US) Food and Drug Administration (FDA) Regulations
โข MedTech Classification Rules and Categories
โข Quality Management Systems (QMS) in MedTech Industry
โข Clinical Evidence and Evaluation for MedTech
โข Post-Market Surveillance (PMS) and Vigilance in MedTech
โข Global Harmonization and Convergence in MedTech Regulations
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