Presented by
Management Forum
An introduction to Risk Management ISO 14971:2019 In-house Training
Achieve proficiency in medical device risk management by mastering ISO14971:2019, incorporating precise assessment, strategic analysis, and effective mitigation strategies.
Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
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 constructed the Introduction to Risk Management ISO14971 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
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
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
This course will cover:
What is risk management?
ISO 14971 standard and risk management planning
- Intro to the ISO standard and its significance in the medical device industry Basic Principles of Risk Management
- Understanding the fundamental principles of risk management as outlines in ISO
- Identification of key terms, definitions and concepts related to risk.
- Guidelines for developing a risk management plan in accordance with the ISO.
- Determining the scope of risk management activities and establishing objectives
- Clarification of roles and responsibilities within the context of risk management.
- Discussion on the involvement of different stakeholders in the risk management process.
- Guidance on how the ISO aligns with regulatory requirements for medical devices.
- Ensuring that risk management practices comply with applicable international regulations.
Risk assessment
- Criteria for evaluating and assessing risks.
- Determining acceptable risk levels and making risk acceptability decisions
Risk controls
- Strategies for implementing risk control measures to reduce or eliminate identified risks.
- Integration of risk controls into the design and development process
Benefit-risk analysis
- Intro to various risk analysis techniques prescribed by the ISO.
- Practical application of risk analysis methods, such as hazard analysis, fault tree analysis and failure mode and effects analysis
Risk management report & post-production activities
- Requirements for documenting and maintaining records of the risk management process.
- Best practices for creating comprehensive documentation that meets regulatory standards.
- Understanding the application of risk management at various stages of the medical device lifecycle
- Incorporating risk management into design, manufacturing, post-market surveillance and other phases
Linda Garrod
Ivdeology
Linda 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.
