ISO 14971:2019 Risk Management for Medical Devices
Select Other "city & date"
ISO 14971:2019 Risk Management for Medical Devices Course
Introduction:
Effective risk management plays a crucial role in all processes within the medical device industry. Dr. Peter Bowness, the Medicinal and Biologics Technical Team Manager, provides insights into the updated version of ISO 14971 and highlights the key changes from the previous standard.
The training course on Risk Management for Medical Devices ISO 14971:2019 aims to enhance participants' understanding of how ISO 14971:2019 influences the decision-making process in medical device manufacturing. It enables professionals in the field to grasp the potential improvements that can be achieved in their business and risk management practices through the implementation of ISO 14971:2019.
Throughout the course, practical activities are incorporated to offer attendees the opportunity to apply their skills and engage in risk management activities. By the end of the course, participants will be equipped to integrate these risk management practices within their organization.
Course Objectives:
Upon completion of the Risk Management for Medical Devices ISO 14971:2019 training course, you will be able to:
- Interpret the regulations pertaining to 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 term 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