Professional Certificate in Medical Device Regulatory Compliance and Risk Mitigation
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Compliance and Risk Mitigation is a crucial course for professionals seeking to navigate the complex regulatory landscape of the medical device industry. This program covers essential topics such as FDA regulations, EU MDR, quality management systems, and risk management strategies.
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โข Regulatory Framework for Medical Devices
โข Understanding Global Medical Device Regulations
โข Quality System Requirements and Standards (ISO 13485)
โข Design Control and Risk Management (ISO 14971)
โข Clinical Evaluation and Post-Market Surveillance
โข Medical Device Classification and Labeling
โข Compliance with FDA Regulations and EU MDR
โข Effective Complaint Handling and Adverse Event Reporting
โข Internal Audits and Management Review for Compliance
โข Strategies for Risk Mitigation in Medical Device Industry
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