Course overview
Understand the use of risk management in the medical device industry and how to review and construct risk management documentation to meet both quality and regulatory requirements.
The global regulation of medical devices is increasingly taking the risk based approach, whether that be when building a quality management system or building technical documentation for registrational submissions. ISO 14971:2019 is the international standard which supports the assessment of risks and construction of compliant risk management documentation to support these areas.
Linda Garrod of IVDeology has developed the course to provide participants with foundational knowledge and practical skills related to the application of ISO14971:2019, an international standard for medical device risk management.
Key topics to be addressed:
- Overview of ISO14971:2019
- Risk management framework
- Risk management planning
- Risk analysis techniques
- Risk evaluation and acceptability
- Risk control measures
- Documentation and record keeping
- Risk management throughout the product lifecycle
- Compliance with regulatory requirements
CPD Hours: 3
Course Content
- Day 1
- What is risk management?
- ISO 14971 standard and risk management planning
- Risk assessment
- Risk controls
- Benefit-risk analysis
- Risk management report & post-production activities
