FREE ON-DEMAND WEBINAR
October 15, 2024

Clinical Submission Do's & Don’ts: Tips from a Former Notified Body Expert

A clinical evaluation is essential for demonstrating a medical device’s safety and performance, ensuring it meets regulatory standards such as the EU MDR. Likewise, the clinical evaluation documentation plays a critical role in medical device regulatory submissions, as any missteps could delay approvals and jeopardize market access.

In this free webinar, Dr Yvonne Ndefo, former Chief Clinical Evaluator at NSAI, currently working as a medical device consultant, will share key insights on how to create robust clinical submissions that satisfy Notified Bodies' rigorous requirements.

Whether you're new to clinical evaluation documentation or seeking to enhance your submission process, this session will provide actionable strategies and expert guidance to help you ensure regulatory compliance and streamline your documentation efforts.

Specifically, this webinar will help you:

• Understand the essential components of a comprehensive Clinical Evaluation Report (CER)
• Learn how to ensure completeness and compliance in your clinical documentation
• Identify common pitfalls in clinical submissions and how to avoid them
• Gain expert recommendations for engaging with regulatory bodies early in the process