Risk Management / Risk Analysis for Medical Devices

To provide understanding of risk management as well as risk analysis and how they apply to medical devices; to develop the skills necessary to apply risk management and risk analysis methodologies, such as FMEA, to medical devices throughout product life cycle.

Risk is a measurable factor. It is defined by safety specialists as a function of hazard severity and the probability that a hazard will occur. Safety, however, cannot be measured precisely. It requires a judgment by designers and production professionals acting together with management, taking account of what is technically and economically feasible. The assessment of safety involves balancing the risks that cannot be eliminated from the product against the benefit and utility of the product. These two factors (probability and severity) form the basis for a product safety profile, which provides management with information to decide whether to bring a device to market.

Risk management is required by ISO 13485:2003. Risk analysis is required by FDA’s Quality System Regulation (QSR) and the Annex I Essential Safety Requirements of the European Union’s three Medical Devices Directives (Active Implantable, Medical Devices and In Vitro Diagnostics). The EU requires a risk analysis for all medical device product family technical files, including those already on the market. The FDA initiated its risk analysis expectations on June 1, 1996 and requirement June 1, 1997. Risk management/risk analysis are not only required during design control, but throughout the entire product life cycle including all aspects of Product Realization. For sterile packaging, risk analysis is expected for design validation, process validation and distribution validation.

This 2-day course examines both risk analysis and risk management and is designed to give practical applications of these methodologies to their devices and device packaging (where relevant). For risk management, participants will review the application of the ISO 14971 standard for medical devices. Participants also will review the use of FMEA (Failure Mode and Effects Analysis) and FTA (Fault Tree Analysis) to conduct risk analysis to identify hazards, their severity and the probability they might occur.

Using case studies, hypothetical devices or actual company devices, and interactive discussions, participants will apply the principles of risk analysis to medical devices. Following the risk analysis, participants will apply risk management principles to their devices including regulatory requirements, technical costs, accident costs, liability costs and insurance costs, which affect decision making on the acceptability of risks in bringing a device to market.

• Understand the expectations of FDA and the EU in applying risk analysis to medical devices
  
• Understand the application of the ISO 14971 standard to medical devices
  
• Understand the application of risk analysis methodologies such as FMEA and FTA to medical devices
  
• Understand the principles of risk management planning in developing procedures and practices to analyze, evaluate and control risks
  
• Learn how to use a product safety audit to identify potential areas of risk exposure and liability exposure