Medical Device Risk Management Per ISO 14971 Essentials Training by Tonex
Medical Device Risk Management Per ISO 14971 Essentials Training by Tonex provides an in-depth understanding of how to identify, analyze, evaluate, and control risks associated with medical devices throughout their lifecycle. The training aligns with ISO 14971:2019, the globally recognized standard for risk management in the medical device industry. Participants will explore critical aspects such as hazard identification, risk acceptability criteria, residual risk evaluation, and post-market surveillance strategies. Additionally, the course highlights how robust risk management frameworks directly impact cybersecurity by minimizing vulnerabilities and ensuring secure design controls—an essential factor in protecting both patient safety and healthcare data integrity.
Audience:
- Medical device engineers
- Quality assurance professionals
- Regulatory affairs specialists
- Compliance officers
- Risk management teams
- Cybersecurity professionals
Learning Objectives:
- Understand ISO 14971 risk management framework
- Conduct effective risk analysis and evaluation
- Develop risk control measures
- Apply risk-benefit analysis and residual risk management
- Implement post-market surveillance activities
- Recognize cybersecurity implications in device risk management
Course Modules:
Module 1: ISO 14971 Overview
- Purpose and scope of ISO 14971
- Key definitions and principles
- Risk management lifecycle stages
- Integration with design and development
- Regulatory and legal alignment
- Cybersecurity considerations overview
Module 2: Risk Analysis Process
- Hazard identification techniques
- Foreseeable misuse assessment
- Risk estimation methods
- Use of preliminary hazard analysis
- Documentation requirements
- Cyber risks in embedded systems
Module 3: Risk Evaluation Techniques
- Establishing acceptability criteria
- Severity and probability ranking
- Decision-making frameworks
- Stakeholder impact assessment
- Data sources for evaluation
- Addressing cyber threat vectors
Module 4: Risk Control Strategies
- Hierarchy of risk control options
- Design and process modifications
- Protective measures implementation
- Information for safety labeling
- Verification of control effectiveness
- Cybersecurity-by-design approach
Module 5: Benefit-Risk Analysis
- Evaluating medical benefits
- Balancing clinical and operational risks
- Handling residual risks
- Risk communication methods
- Informed decision-making process
- Cyber-risk tradeoff evaluation
Module 6: Post-Market Surveillance
- PMS plan and data collection
- Incident trend analysis
- Field action criteria
- Feedback into risk management
- Regulatory reporting obligations
- Cybersecurity updates and monitoring
Elevate your expertise in medical device safety and compliance. Enroll now in the Medical Device Risk Management Per ISO 14971 Essentials Training by Tonex and build a solid foundation in managing risks—technical, clinical, and cybersecurity-related—for safer, regulation-ready medical products.