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
Benefits of attending
- Understand the use of a risk-based approach and how ISO14971 supports this
- Gain a clear understanding of ISO14971 content and the use of key terminology
- Review each step In the risk management pathway to fully understand expected analysis and content
- Be able to identify the content expected for each type of risk management record
- Understand the use of well constructed risk management documentation to support post market device analysis and complaint handling
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Course Content
What is risk management?
Course Provider
Linda Garrod,
IvdeologyLinda Garrod is a Quality Specialist at IVDeology Ltd, based in Kent, UK. She brings her exceptional quality experience from 20 years within the medical device industry, to support manufacturers in the creation and continual improvement of Quality Management Systems, compliant with the demands of ISO 13485, MDSAP and CE IVDR.
Who Should Attend
Risk Management is a function that is best served by a cross department team to ensure all aspects have been identified and unacceptable risks mitigated. This course is particularly important for those working in the medical device industry, including:
- Medical device managers who must sign off on risk management files
- Regulatory professionals
- Quality specialists
- Research and development scientists
- Manufacturers
- Clinical support team members
