Udem Atlantic- EU MDR in Practice: Insights from a Notified Body Perspective

Description

Join us for an insightful session on EU MDR and how to successfully navigate the certification process — combining Notified Body expertise with hands-on technical documentation insights.

As MDR requirements continue to evolve, medical device manufacturers face increasing challenges in aligning their technical documentation, clinical evidence, and quality systems with regulatory expectations.

In this session, we will share practical insights from a Notified Body perspective, along with real-world approaches to technical documentation and post-market surveillance (PMS) — helping you better prepare for a smoother and more efficient MDR journey.

Hosted by UDEM Atlantic, the U.S. office of European Notified Body 2292, this webinar brings together expertise in:

Key topics will include:

• Overview of the EU MDR certification process
• Notified Body expectations during assessments
• Common gaps in clinical evidence and documentation
• How to structure technical documentation to reduce delays
• Practical insights into Post-Market Surveillance (PMS)

Whether you are preparing for MDR certification or optimizing your current strategy, this session will provide actionable insights to support your next steps.

Register here: 

https://events.zoom.us/ev/AlGaC3dSvEnuNm_OAR-5zVcDz5foKu7kVLCVyvR0bjuMkpftsYbZ~ApgFQNy6rMmQ3AbNlIMND_H0W6b1q0tikwstB_NEIJznmN39NnAof-R7jQ