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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⢠Regulatory Frameworks: Understanding global regulations and guidelines for healthcare device compliance
⢠Risk Management: Implementing ISO 14971 and conducting risk assessment for medical devices
⢠Quality Management Systems: Establishing and maintaining QMS according to ISO 13485
⢠Design Control: Applying FDA design control requirements in product development
⢠Clinical Evaluation: Conducting clinical evaluations and preparing clinical evaluation reports
⢠Labeling and Packaging: Ensuring compliance with UDI, IFU, and other labeling requirements
⢠Post-Market Surveillance: Managing vigilance, PMS, and PSURs for continuous improvement
⢠Supply Chain Management: Ensuring compliance throughout the entire supply chain
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