Professional Certificate in Medical Device Regulatory Affairs Management
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Affairs Management is a crucial course for professionals seeking expertise in navigating the complex regulatory landscape of the medical device industry. This program, designed by industry experts, addresses the growing need for professionals who can ensure compliance with intricate regulations, driving successful market access and product innovations.
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โข Regulatory Framework for Medical Devices
โข Medical Device Classification and Risk Management
โข Quality System Requirements for Medical Devices
โข Design Control and Design History Files for Medical Devices
โข Clinical Evaluation and Post-Market Surveillance
โข Medical Device Labeling, Instructions for Use, and User Interface Design
โข Regulatory Submissions and Approvals for Medical Devices
โข Global Harmonization and International Medical Device Regulations
โข Vigilance and Adverse Event Reporting for Medical Devices
โข Audit and Inspection Readiness in Medical Device Regulatory Affairs
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