Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
This webinar will explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices.
We’ll discuss the critical role of clinical validation starting from the design phase and guide you on how to compile the necessary evidence to meet MDR requirements.
By attending, you’ll learn how to ensure your software not only achieves market access but also upholds patient safety and delivers effective healthcare outcomes.
Agenda
00:00 – Introduction
05:45 – Regulation & Guidance
07:40 – Clinical Evidence
16:49 – General Safety Performance Requirements
17:59 – Systematic Literature Review
23:02 – Clinical Evaluation
35:22 – Benefit Risk Assessment
07:40 – Clinical Evidence
16:49 – General Safety Performance Requirements
17:59 – Systematic Literature Review
23:02 – Clinical Evaluation
35:22 – Benefit Risk Assessment
46:02 – Q&A
Speaker
Pia Gyselen
Lead Medical Writer
Expert knowledge in Medical Devices
Let’s get your medical device to market. We support you from concept to launch in the full lifecycle.