Global Certificate in Healthcare Device Compliance Essentials Fundamentals
-- ViewingNowThe Global Certificate in Healthcare Device Compliance Essentials Fundamentals is a comprehensive course designed to meet the growing industry demand for professionals with expertise in healthcare device compliance. This course emphasizes the importance of understanding regulations and standards to ensure the safety and effectiveness of medical devices.
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โข Regulatory Frameworks: Understanding global regulations and guidelines for healthcare device compliance
โข Risk Management: Implementing ISO 14971 and conducting risk assessment for medical devices
โข Quality Management Systems: Establishing and maintaining QMS according to ISO 13485
โข Design Control: Applying FDA design control requirements in product development
โข Clinical Evaluation: Conducting clinical evaluations and preparing clinical evaluation reports
โข Labeling and Packaging: Ensuring compliance with UDI, IFU, and other labeling requirements
โข Post-Market Surveillance: Managing vigilance, PMS, and PSURs for continuous improvement
โข Supply Chain Management: Ensuring compliance throughout the entire supply chain
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