ISO 14971 Risk Management for Medical Devices Training by Tonex
ISO 14971 Risk Management for Medical Devices Training Course provides participants with a comprehensive understanding of the principles, requirements, and best practices for managing risks in the development and lifecycle of medical devices. It covers the application of ISO 14971 in ensuring the safety and effectiveness of medical devices, as well as compliance with regulatory requirements.
Audience:
This course is designed for professionals involved in the design, development, manufacturing, quality assurance, regulatory affairs, and post-market activities of medical devices. It is suitable for engineers, project managers, quality managers, regulatory specialists, and other stakeholders engaged in the medical device industry.
Learning Objectives:
By the end of the course, participants will:
Understand the principles and concepts of risk management in the context of medical devices.
- Gain a thorough knowledge of ISO 14971 and its application in the development and lifecycle of medical devices.
- Learn how to identify, analyze, evaluate, and control risks associated with medical devices.
- Familiarize themselves with risk management tools, techniques, and documentation requirements.
- Develop the skills to apply ISO 14971 effectively in their organizations and projects.
- Gain insights into best practices for risk management in the medical device industry.
- Understand the relationship between ISO 14971 and other relevant standards and regulatory requirements.
Course Outline:
Introduction to Medical Device Risk Management
- Overview of risk management principles
- Importance of risk management in the medical device industry
- Regulatory framework and standards related to medical device risk management
Fundamentals of ISO 14971
- Introduction to ISO 14971 standard
- Scope, objectives, and requirements of ISO 14971
- Relationship between ISO 14971 and other standards and regulations
Risk Management Process
- Steps involved in the risk management process
- Risk management planning and establishing the risk management framework
- Risk identification, analysis, evaluation, and control measures
- Residual risk assessment and risk acceptance
Risk Management Tools and Techniques
- Risk assessment methods (qualitative, semi-quantitative, quantitative)
- Risk matrices and scoring systems
- Fault tree analysis, failure mode and effects analysis (FMEA), and other tools
Risk Management Documentation
- Documentation requirements and best practices
- Risk management file and its contents
- Traceability and record-keeping in risk management
Integration of Risk Management in the Medical Device Lifecycle
- Risk management in design and development processes
- Risk management in manufacturing and production
- Post-market surveillance and risk management activities
Case Studies and Practical Exercises
- Analyzing real-world examples of risk management in medical devices
- Hands-on exercises to apply risk management principles and techniques
Best Practices and Lessons Learned
- Industry best practices for effective risk management
- Case studies highlighting successful risk management implementation
- Lessons learned and common pitfalls to avoid
Regulatory Compliance and Audits
- Ensuring compliance with regulatory requirements
- Preparing for risk management audits and inspections
- Addressing non-compliance and corrective actions
Future Trends and Evolving Practices
- Emerging trends and advancements in medical device risk management
- Considerations for risk management in innovative technologies and complex devices
- Impact of digital health and connected devices on risk management