Certificate in Global Medical Device Standards
-- ViewingNowThe Certificate in Global Medical Device Standards is a comprehensive course designed to equip learners with the essential skills needed for success in the medical device industry. This program focuses on the importance of global standards, regulations, and quality systems in the development, production, and distribution of medical devices.
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โข Introduction to Global Medical Device Standards
โข Understanding ISO 13485: Medical Devices - Quality Management Systems
โข Regulatory Affairs for Global Medical Device Market
โข Overview of FDA (US Food and Drug Administration) Requirements
โข European Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)
โข International Medical Device Regulatory Frameworks
โข Risk Management and Clinical Evaluation in Medical Devices
โข Quality Assurance and Control in Medical Device Manufacturing
โข Post-Market Surveillance and Vigilance in Global Medical Devices
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