Risk Analysis and FMEA for Medical Devices

On the first day of this 2-day interactive and practical course you will learn about the requirements of ISO 14971 and how to carry out risk analysis from start to finish. The second day will explore in greater depth the role of FMEA and how to apply it in your risk management process.

As well as workshops and discussions around topics such as hazard Identification and risk control and reduction, delegates will have the opportunity to talk as a group about the stages of FMEA.

• R&D managers/engineers
• RA/QA managers/engineers
• management representatives
• members of multi-discipline design teams
• members of design review teams
• sales and marketing management
• product, project, and programme managers
• internal auditors

If you would like to understand risk analysis and control in bringing medical devices to market without further detail around FMEA, you may like to look at our 1-day ISO 14971 Risk Analysis for Medical Devices training course.

• expectations of the FDA and the EU in applying risk analysis to medical devices
• risk management requirements and the purpose of ISO 14971
• the application of ISO 14971 to medical devices
• the application of risk analysis methodologies such as FMEA to medical devices
• the principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks
• sources of information and further development

• apply the process to conduct risk analysis to identify hazards, their severity and the probability they might occur
• apply risk analysis methodologies to medical devices
• apply risk evaluation and risk control principles to their devices – including regulatory requirements, technical costs, accident costs, liability costs and insurance costs – all of which feed into decision-making around acceptability of risks when bringing a device to market

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