Training Course in Medical Device Risk Assessment

Introduction to Medical Risk Assessment

• Definition of risk assessment in the context of medical devices.

• Relationship between risk management and medical product quality.

• Key objectives of risk assessment throughout the device lifecycle.

Regulatory and Standards Framework for Medical Devices

• Overview of ISO 13485 and ISO 14971 standards.

• Regulatory requirements from international authorities (FDA, CE, MHRA).

• Role of risk management in achieving regulatory compliance.

Risk Analysis Methodology for Medical Devices

• Identification and classification of risk sources.

• Risk analysis techniques: FMEA, FTA, and HAZOP.

• Using matrices to assess risk severity and probability.

Assessment of Clinical and User Impacts

• Analyzing risks related to human use.

• Evaluating clinical consequences of technical failures.

• Importance of user feedback in updating risk assessments.

Risk Assessment Throughout the Product Lifecycle

• Applying risk management during design and development phases.

• Monitoring performance during operation and maintenance.

• Post-market review and continuous incident analysis.

Documenting the Risk Management Process

• Requirements for the Risk Management File.

• Preparing risk assessment and analysis reports.

• Documenting supporting evidence and updating records.

Identifying Risk Control and Mitigation Measures

• Strategies for reducing risks in engineering design.

• Implementing preventive controls and effective corrective actions.

• Balancing risk levels with clinical benefits of the device.

Analyzing the Effectiveness of Implemented Controls

• Verifying the effectiveness of preventive measures.

• Monitoring risk-related performance indicators.

• Conducting periodic reviews to update risk assessments.

Integrated Risk Management System in Healthcare Institutions

• Designing a comprehensive administrative framework for risk management.

• Defining responsibilities and roles within the system.

• Integrating risk assessment with quality and safety management systems.

Recent Trends in Medical Device Risk Assessment

• Use of artificial intelligence and data analytics in risk management.

• Digital transformation and its role in medical device monitoring.

• Future trends in safety standards and global certification.