Executive Development Programme in Medical Device Regulatory Excellence
-- ViewingNowThe Executive Development Programme in Medical Device Regulatory Excellence is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the medical device industry. This programme is critical for career advancement in this field, as it provides learners with a comprehensive understanding of regulatory strategies, quality management systems, and global regulatory compliance.
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⢠Introduction to Medical Device Regulatory Excellence
⢠Global Regulatory Landscape for Medical Devices
⢠Understanding Regulatory Pathways and Classification of Medical Devices
⢠Quality Management Systems and ISO 13485 Compliance
⢠Design Control and Risk Management for Medical Devices
⢠Clinical Evaluation and Post-Market Surveillance
⢠Labeling, Advertising, and Promotion of Medical Devices
⢠Regulatory Submissions and Approvals
⢠MDR, IVDR, and Post-Market Compliance
⢠Global Regulatory Strategy and Harmonization Initiatives
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