Executive Development Programme in Medical Device Regulations
-- ViewingNowThe Executive Development Programme in Medical Device Regulations is a certificate course designed to provide learners with comprehensive knowledge of global regulatory norms and quality standards in the medical device industry. This programme emphasizes the importance of regulatory compliance and its role in ensuring patient safety and product efficacy.
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โข Introduction to Medical Device Regulations
โข Global Regulatory Landscape for Medical Devices
โข Quality Management Systems in Medical Device Manufacturing
โข Clinical Evaluation and Post-Market Surveillance
โข Risk Management in Medical Devices
โข Regulatory Affairs for Medical Devices
โข Labeling, Packaging, and Sterilization of Medical Devices
โข Medical Device Vigilance and Adverse Event Reporting
โข EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
โข U.S. Food and Drug Administration (FDA) Regulations and Compliance for Medical Devices
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