In this one day course we explore clinical investigations for medical devices. We will review the latest legislation and its impact on determining whether a clinical trial is required. Our experienced trainer will guide you through the key stages in designing and executing your clinical investigation. Through practical exercises delegates will tackle common challenges and develop strategies to overcome them.
• Understand how to determine whether or not a clinical investigation is required
• Describe the key points of the MDR and their impact on clinical investigations
• Discuss common challenges in project managing and monitoring clinical investigations and how to overcome them
• Overview of MD classifications EU and US
• When do you need to do a clinical trial?
• Update on the MDR and the impact it will have on clinical investigations
• Review of other relevant directives and guidance including ISO 14155
• Designing your clinical investigation
• Key Points for Project Managing a clinical investigation
• Key Points for Monitoring a clinical investigation
• Medical Devices and Safety Monitoring in Clinical Investigations
• What about drug device combinations?