Global Certificate in Healthcare Device Regulatory Compliance Essentials
-- ViewingNowThe Global Certificate in Healthcare Device Regulatory Compliance Essentials is a crucial course for professionals seeking to navigate the intricate world of medical device regulation. This program addresses the growing industry demand for experts who can ensure compliance with complex and evolving regulatory frameworks.
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โข Regulatory Foundations: Understanding Global Regulatory Bodies (FDA, EU MDR, etc.)
โข Medical Device Classification: Defining Device Risk Levels and Implications
โข Regulatory Pathways: Clearing, Approval, and Post-Market Processes
โข Labeling and Packaging: Ensuring Compliance with Global Standards
โข Clinical Data and Trials: Collecting, Analyzing, and Reporting
โข Quality Management Systems: Implementing and Maintaining QMS for Compliance
โข Design Controls: Applying Principles to Ensure Safe and Effective Devices
โข Risk Management: Identifying, Assessing, and Controlling Risks in Medical Devices
โข Post-Market Surveillance: Monitoring and Reporting Adverse Events and Trends
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