Certificate in Healthcare Risk Assessment for Medical Devices
-- ViewingNowThe Certificate in Healthcare Risk Assessment for Medical Devices is a comprehensive course designed to equip learners with critical skills in managing risks associated with medical devices. This course is crucial in the current healthcare landscape, where there is an increasing demand for professionals who can ensure patient safety and regulatory compliance.
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โข Introduction to Healthcare Risk Assessment for Medical Devices: Understanding the fundamentals of risk assessment in the healthcare industry, with a specific focus on medical devices.
โข Regulatory Frameworks: An overview of domestic and international regulations governing medical device risk assessment, including FDA and EU MDR.
โข Medical Device Classification: Identifying different classes of medical devices, their associated risks, and the required risk assessment processes.
โข Risk Management Standards: Exploring the role of ISO 14971 and IEC 60601 in medical device risk management and risk assessment.
โข Hazard Identification: Techniques for identifying and categorizing potential hazards associated with medical devices.
โข Risk Analysis: Strategies for assessing and prioritizing risks, determining risk control measures, and creating risk evaluation reports.
โข Risk Control and Reduction: Implementing risk reduction measures, designing risk management files, and ensuring compliance with regulatory requirements.
โข Post-Market Surveillance: Monitoring and evaluating medical devices post-market to identify emerging risks and ensure ongoing safety.
โข Effective Communication and Documentation: Techniques for effectively communicating risk assessment findings and maintaining comprehensive documentation.
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