Certificate in Medical Device Regulations and Quality Systems
-- ViewingNowThe Certificate in Medical Device Regulations and Quality Systems course is a comprehensive program designed to provide learners with a solid understanding of the regulations and quality systems crucial in the medical device industry. This course highlights the importance of compliance with FDA regulations, ISO 13485, and EU MDR, enabling learners to ensure the safety and efficacy of medical devices throughout their lifecycle.
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โข Introduction to Medical Device Regulations
โข Medical Device Classification and Risk Management
โข Quality System Regulation (QSR) and ISO 13485
โข Design Control and Documentation Requirements
โข Medical Device Labeling, Tracing, and UDI Systems
โข Complaint Handling, MDRs, and Adverse Event Reporting
โข Sterilization, Validation, and Production Control
โข Medical Device Clinical Trials and Post-Market Surveillance
โข Import/Export Controls and International Regulations
โข Audit and Inspection Preparation for Medical Devices
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