ISO 14971: Risk Management for Medical Devices Essentials Training by Tonex
ISO 14971 provides a structured approach to risk management for medical devices. This training covers key principles, regulatory requirements, and best practices for implementing risk management throughout the product lifecycle. Participants will learn how to identify hazards, assess risks, and apply effective controls to ensure compliance and patient safety. The course also explores documentation, risk-benefit analysis, and post-market surveillance strategies. Designed for professionals in medical device development, this program enhances understanding of risk management processes, regulatory expectations, and industry standards.
Audience:
- Medical device manufacturers
- Regulatory affairs professionals
- Quality assurance specialists
- Risk management teams
- Compliance officers
- Product development engineers
Learning Objectives:
- Understand ISO 14971 risk management framework
- Identify and assess risks in medical device development
- Learn best practices for hazard identification and mitigation
- Ensure compliance with regulatory requirements
- Implement effective risk control measures
Course Modules:
Module 1: Introduction to ISO 14971 and Risk Management
- Overview of ISO 14971 and its importance
- Risk management principles in medical devices
- Key terminology and definitions
- Regulatory expectations for risk management
- Stages of the risk management process
- Importance of documentation and record-keeping
Module 2: Hazard Identification and Risk Analysis
- Methods for identifying hazards in medical devices
- Risk estimation techniques and assessment tools
- Failure modes and effects analysis (FMEA)
- Identifying foreseeable misuse and abnormal use
- Evaluating severity and probability of risks
- Best practices for conducting risk assessments
Module 3: Risk Evaluation and Control Measures
- Criteria for risk acceptability in medical devices
- Applying risk-benefit analysis for decision-making
- Selection of appropriate risk control measures
- Design and process controls to mitigate risks
- Implementation of risk control strategies
- Verification of effectiveness and residual risk assessment
Module 4: Risk Management Plan and Documentation
- Components of a comprehensive risk management plan
- Developing and maintaining a risk management file
- Importance of traceability in risk management activities
- Risk management report requirements
- Integration of risk management with quality systems
- Common documentation challenges and solutions
Module 5: Post-Market Surveillance and Risk Monitoring
- Role of post-market surveillance in risk management
- Collecting and analyzing post-market data
- Handling complaints and adverse event reporting
- Risk reevaluation and lifecycle management
- Implementing corrective and preventive actions (CAPA)
- Regulatory requirements for ongoing risk assessment
Module 6: Compliance, Audits, and Best Practices
- Understanding ISO 14971 compliance requirements
- Aligning risk management with regulatory audits
- Common pitfalls and non-compliance issues
- Best practices for continuous risk management
- Case studies on successful risk management strategies
- Preparing for internal and external audits
Take the next step in mastering risk management for medical devices. Enroll in ISO 14971: Risk Management for Medical Devices Essentials Training by Tonex today!