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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⢠Regulatory Landscape and Medical Device Classification
⢠Quality Management System (QMS) for Medical Devices
⢠Design Control and Risk Management for Medical Devices
⢠Preparing and Compiling Technical Documentation
⢠Medical Device Labeling, Instructions for Use (IFU), and Packaging
⢠Understanding and Navigating FDA Submission Processes
⢠EU MDR and IVDR Compliance and Submission Strategies
⢠Post-Market Surveillance and Vigilance Reporting
⢠Strategies for Effective Communication with Regulatory Authorities
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