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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⢠Introduction to Medical Device Regulations
⢠Global Regulatory Landscape for Medical Devices
⢠Quality Management Systems in Medical Device Manufacturing
⢠Clinical Evaluation and Post-Market Surveillance
⢠Risk Management in Medical Devices
⢠Regulatory Affairs for Medical Devices
⢠Labeling, Packaging, and Sterilization of Medical Devices
⢠Medical Device Vigilance and Adverse Event Reporting
⢠EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
⢠U.S. Food and Drug Administration (FDA) Regulations and Compliance for Medical Devices
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