Dates and Venues

Learn about the steps of the risk assessment process and its application specifically to medical devices on this ISO 14971 Risk Analysis for Medical Devices training course.

On this practical 1-day course you will examine all steps of the risk management process, from risk analysis and risk evaluation through risk control to post-production information gathering.

The course employs interactive workshops to allow you to practise what you are learning, as well as group discussions on topics such as risk control, hazard identification and techniques for risk analysis.

This course is suitable for designers, production professionals and managers who need to work together to measure risk and promote safety. These include:

  • 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 wish to explore more deeply into Failure Mode and Effects Analysis (FMEA) at the same time as learning about risk analysis, we recommend you look at our 2-day Risk Analysis and FMEA for Medical Devices training course.

Key topics covered on this course include:

  • 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 principles of risk management planning in developing procedures and practices to analyse, evaluate and control risks
  • sources of information and further development

This typical course structure ensures key topics are covered:

  • WELCOME AND INTRODUCTION
  • Module 1 Introduction to Risk
  • Module 2 Risk Policy
  • Module 3 Scope & Definitions
  • Module 4 Risk Process, Plan, File
  • Module 5 Risk Analysis
  • Module 6 Risk Analysis Continued: Usability
  • Module 7 Risk Estimation
  • Module 8 Risk Analysis – Techniques
  • Module 9 Risk Evaluation
  • Module 10 Risk Control
  • Module 11 Residual Risk Evaluation
  • Module 12 Benefit-risk Analysis
  • Module 13 Evaluation of Overall Residual Risk
  • Module 14 Risk Management Review
  • Module 15 Production and Post-production Activities
  • Course Review and Evaluation
  • CLOSE

By the end of this training course on risk analysis for medical devices, delegates will be able to:

  • apply the process to conduct risk analysis to identify hazards, their severity and the probability that they might occur
  • 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

An ISO 14971 Risk Analysis for Medical Devices Training Course certificate will be awarded to delegates who complete all elements of the course.

ISO 14971 Risk Analysis for Medical Devices Certificate