ISO 14971:2019 Risk Management for Medical Devices
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ISO 14971:2019 Risk Management for Medical Devices Course
Introduction:
In the medical device industry, risk management is a vital part of all your company’s processes. Hear from Dr Peter Bowness, Medicinal and Biologics Technical Team Manager, about the updated ISO 14971 and what has changed from the previous version of the standard.
Risk Management for Medical Devices ISO 14971:2019 training course enables a greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices. It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.
Practical activities throughout the day will allow you to apply your skills, and implement risk management activities so that these can be embedded within the organization upon completion of the course.
Course Objectives:
Upon completion of the Risk Management for Medical Devices ISO 14971:2019 training course, you will be able to:
- Interpret the regulations about Risk Management and ISO 14971 in particular.
• Identify and quantify risks associated with medical devices.
• Decide on the acceptability of those risks.
• Re-evaluate risks following corrective action.
• Different advanced risk assessment techniques.
• HAZOP methodology and its applications.
• Quantitative Risk assessment (QRA).
• 3 types of evaluation of risks: Qualitative, Semi-Quantitative, and Quantified.
• Methodology of Failure Mode and Effects Analysis (FMEA).
• Evaluating risk control, residual risk, and acceptable risk, in terms of the safety of medical devices
Who Should Attend?
Risk Management for Medical Devices ISO 14971:2019 training course is ideal for:
- Managers, Engineers, Executives,
- Supervisors of various departments: Quality Assurance, Production, Regulatory Affairs, Laboratory, Logistics, Purchasing,
- Members of the Risk Management Team.
Course Outlines:
- Introduction to risk management and tools and techniques
- Risk management requirements and the purpose of ISO 14971
- The application of ISO 14971 to medical devices
- The principles of risk management planning in developing procedures and practices to analyze, evaluate, and control risks
- Sources of information and further development
