Certificate in Healthcare Risk Assessment for Medical Devices
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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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