This 5-steps masterclass will cover all aspects of clinical evaluation in line with the European Medical Devices Regulation (MDR) 2017/745 and applicable guidance documents.
These 5 courses (31,5 hours of training) are designed to give you the tools and skills you need to clinically evaluate all your medical devices.
You will learn to find your way around the regulatory requirements and guideline documents. You will understand how to appropriately approach the strategic kick-off of a medical device evaluation in the Clinical Evaluation Plan. You will gain the insights of a Clinical Evaluation Report. You’ll discuss best practice on how to prepare Post-Market Clinical Follow-up Plans and Reports, as well as gain insights in common pitfalls and tips on how to prevent them. And finally, you will learn about the Summary of Safety and Clinical Performance, including skills for writing for lay audiences.
An opportunity to learn the insights of the Clinical Evaluation of medical devices through case studies, discussions and examples.