Ex 123 - Risk Analysis for Medical Devices (1 Day)

Overview

Risk is a measurable factor. It is defined by safety specialists as a function of the severity of the hazard and the probability that the hazard will occur. Safety, however, can not be measured precisely. It requires a judgement 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 analysis is required by FDA's Quality System Regulation (QSR) and the Annex I Essential 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 technical files, including those already on the market. Also, risk analysis does not just occur during design control, it should be applied throughout the processes for product realisation.

This one-day course examines all steps of the risk management process. Risk assessment involves risk analysis and risk evaluation, and then comes risk control and finally post-production information gathering. Participants will review the application of this risk management process in the standard ISO 14971 to medical devices.

Using case studies, hypothetical devices or actual company devices, participants will apply the process to conduct risk analysis to identify hazards, their severity and the probability they might occur. Following the risk analysis, participants will apply risk evaluation and risk control 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.

Key Session Topics

• Understand the expectations of FDA and the EU in applying risk analysis to medical devices
  
• Understand the application of the risk analysis standard ISO 14971 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
  

Who Should Attend

• 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 Program Managers
  
• Internal Auditors