Ex 123 - Risk Analysis for Medical Devices  : 2 days

Overview

To provide understanding of risk analysis and how it applies to medical devices; to develop the skills necessary to apply risk analysis methodologies, such as FMEA to medical devices.

This two-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 and 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.  The course is designed to give participants practical applications of these methodologies to their 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 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 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 analyse, 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
  
• Management Representatives
• Internal Auditors