Risk management system for medical devices

In the course, students will gain a thorough understanding of the principles and concepts underlying risk management, as well as the tools and techniques used to identify and assess the risks associated with medical devices, as well as understand the regulatory environment for medical devices and the risk management requirements set out in regulations such as ISO 14971. Students will also learn how to assess and mitigate risks associated with medical devices throughout the product life cycle, including design, manufacture, distribution and use, including evaluating the effectiveness of risk management plans and identifying areas for improvement.