Certificate in Medical Device Regulations: Global Harmonization
-- ViewingNowThe Certificate in Medical Device Regulations: Global Harmonization is a comprehensive course designed to provide learners with a solid understanding of global medical device regulations. This program highlights the importance of harmonization in the medical device industry, reducing compliance costs, and accelerating market access.
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โข Introduction to Medical Device Regulations
โข Global Harmonization: An Overview
โข Regulatory Bodies and their Roles in Medical Device Regulations
โข Medical Device Classification and its Importance in Global Harmonization
โข Quality System Requirements for Medical Devices
โข Labeling and Packaging Regulations for Medical Devices
โข Clinical Evaluation and Post-Market Surveillance of Medical Devices
โข Pre-market Approval and Notification Processes for Medical Devices
โข International Trade Agreements and their Impact on Medical Device Regulations
โข Case Studies on Global Harmonization in Medical Device Regulations
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