The Short Course on Device Risk Management equips participants with essential skills for identifying, assessing, and mitigating risks associated with medical devices. Through a project-based and interactive approach, learners will engage in hands-on activities that foster practical understanding and application of risk management principles in the medical device industry. Participants will be encouraged to publish their findings and insights in Cademix Magazine, enhancing their professional visibility and contributing to the field.
This course delves into critical aspects of device risk management, including regulatory frameworks, risk assessment methodologies, and real-world case studies. Participants will collaborate on projects that simulate actual industry scenarios, allowing them to apply theoretical knowledge in practical settings. By the end of the course, learners will have developed a comprehensive risk management plan for a medical device, preparing them for roles in healthcare, biotech, and related sectors.
Introduction to Device Risk Management
Regulatory Standards and Compliance (ISO 14971)
Risk Assessment Techniques and Tools
Failure Mode and Effects Analysis (FMEA)
Risk Control Strategies and Implementation
Post-Market Surveillance and Reporting
Case Studies of Device Failures and Lessons Learned
Risk Communication with Stakeholders
Developing a Risk Management Plan
Final Project: Creating a Comprehensive Risk Management Strategy for a Medical Device