Professional Certificate in Medical Device Regulatory Submissions
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Submissions is a crucial course designed to meet the growing industry demand for experts skilled in regulatory affairs. This program equips learners with the essential skills needed to navigate the complex regulatory landscape, ensuring compliance and accelerating time-to-market for medical devices.
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โข Regulatory Landscape and Medical Device Classification
โข Quality Management System (QMS) for Medical Devices
โข Design Control and Risk Management for Medical Devices
โข Preparing and Compiling Technical Documentation
โข Medical Device Labeling, Instructions for Use (IFU), and Packaging
โข Understanding and Navigating FDA Submission Processes
โข EU MDR and IVDR Compliance and Submission Strategies
โข Post-Market Surveillance and Vigilance Reporting
โข Strategies for Effective Communication with Regulatory Authorities
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