Laura Lang
Topics
Case example: Clinical evaluation of a software medical device
Clinical evaluation is a central pillar in the conformity assessment of software medical devices, yet it poses unique challenges due to the nature of software-based technologies. In this presentation, Laura Lang shares a practical case example of how clinical evaluation was planned and executed for a software medical device under the EU MDR. The session walks through key steps such as defining the clinical benefit, identifying relevant clinical evidence, and addressing gaps through clinical performance studies or scientific literature. Attendees will gain insights into documentation best practices, common pitfalls, and lessons learned from real-world implementation. The talk is particularly relevant to professionals working with digital health products, regulatory affairs, and clinical affairs.