ISO 14971 (Medical Device Risk Management) Essentials Training by Tonex
This course provides a comprehensive understanding of ISO 14971, the international standard for medical device risk management. Participants will learn risk assessment, control, and monitoring strategies to ensure compliance and patient safety. The training covers regulatory expectations, risk analysis techniques, and best practices for integrating risk management into the product lifecycle. Real-world applications and case studies enhance learning. This course is ideal for professionals involved in medical device development, quality assurance, and regulatory affairs.
Audience:
- Medical device engineers
- Quality assurance professionals
- Regulatory affairs specialists
- Risk management professionals
- Compliance officers
- Product development teams
Learning Objectives:
- Understand the principles of ISO 14971
- Learn risk identification and assessment methods
- Apply risk control strategies in medical device development
- Ensure compliance with regulatory requirements
- Integrate risk management throughout the product lifecycle
Course Modules:
Module 1: Introduction to ISO 14971
- Overview of ISO 14971 and its importance
- Regulatory framework for medical device risk management
- Key definitions and terminology
- Risk management process overview
- Responsibilities of stakeholders
- Relationship with other regulatory standards
Module 2: Risk Management Planning and Documentation
- Developing a risk management plan
- Essential documentation and records
- Defining risk acceptance criteria
- Risk traceability and reporting
- Role of management in risk oversight
- Best practices for maintaining compliance
Module 3: Risk Analysis Process
- Identifying potential hazards in medical devices
- Understanding hazard-related harm scenarios
- Methods for risk estimation and evaluation
- Use of Failure Modes and Effects Analysis (FMEA)
- Conducting preliminary hazard analysis (PHA)
- Common pitfalls in risk analysis
Module 4: Risk Evaluation and Control Measures
- Evaluating risk acceptability based on criteria
- Implementing effective risk control measures
- Risk-benefit analysis considerations
- Residual risk assessment and mitigation
- Hierarchy of risk control strategies
- Monitoring effectiveness of risk controls
Module 5: Risk Management Review and Post-Market Surveillance
- Periodic review of risk management activities
- Post-market data collection and analysis
- Handling field safety corrective actions
- Complaint management and risk updates
- Regulatory reporting requirements
- Continuous improvement in risk management
Module 6: Risk Management Integration into the Product Lifecycle
- Embedding risk management in design and development
- Linking risk management with quality management systems
- Aligning with regulatory submission requirements
- Risk communication with stakeholders
- Lifecycle risk assessment and updates
- Case studies on effective risk management implementation
Take the next step in ensuring medical device safety and compliance. Enroll today to master ISO 14971 risk management strategies!