Webinar 3 – Certify with Confidence & Clarity – Maximize Your Review, Minimize Your Timeline

What is the webinar about?

This webinar focuses on clarity for your path forward to certification through communication. We will provide examples into how manufacturers can work smarter through the review process by optimizing structured dialogue, streamlining dedicated interactive reviews to keep reviews moving.

Who should attend?

This webinar is open to anyone working at a medical device company who is interested in understanding what is allowed by manufacturers and notified bodies for structured dialogue and will provide examples of optimizing communication effectiveness. This includes gaining deeper insights into a fast-track, dedicated interactive review service model to streamline your certification pathway, as well as clarity on what technical reviewers look for in your documentation submissions.

What will participants gain?

Participants will learn how fast-track review models streamline the process and provide insights into how active BSI Notified Body interactions work seamlessly throughout the review. 

Participants will also leave with a clear understanding on how to address Notified Body expectations and prepare well-supported responses that help close the review loop more efficiently.

—

This is the last of three‑part webinar series designed to help medical device manufacturers navigate EU MDR & IVDR with confidence and predictability. Across the series, our experts unpack how clearer alignment and early collaboration with BSI support the Breakthrough Device (BtX) pathway, effective use of Structured Dialogue, and fast‑track, interactive review models that reduce rework and protect timelines.