Webinar
Medical Devices

Certify with Confidence & Clarity - Maximize Your Review

Understand how to address Notified Body expectations and prepare well-supported responses that help close the review loop more efficiently.

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Gain deeper insight into minimizing your timeline

This webinar focuses on clarity for your path forward to certification through communication.

How manufacturers can work smarter through the review process by optimizing structured dialogue.
Learn how fast-track review models streamline the process.
Insights into how active BSI Notified Body interactions work seamlessly throughout the review.
How to address Notified Body expectations and prepare well-supported responses.

Speakers

Hear from the experts in this webinar

Speaker

Tamara Widenhouse

Technical Team Manager - Vascular Devices, BSI

Speaker

Lauren Burns

Associate Global Head - General Devices, BSI

BSI Insights Series: Better Together

Additional resources to support you

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.
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.

This also includes:

Professionals in Regulatory Affairs.

Clinical and Medical Affairs.

R&D.

Quality.

Senior leadership.
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 webinar offers a clear, practical overview of the Breakthrough Device (BtX) designation pathway under EU MDR and EU IVDR, as clarified in MDCG 2025‑9. Learn how to cut through complexity with Richard Holborow, BSI's Head of Clinical Compliance and how EU expert panels assess applications and clinical evidence.

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This webinar shows manufacturers how to work more effectively with BSI by getting the fundamentals right early. We’ll start with onboarding – aligning on conformity assessment stakeholders, expectations, and readiness so your review begins with fewer surprises.

Then we’ll demystify Structured Dialogue and show how to use it to resolve ambiguity upfront, reduce rounds of review questions, and how to protect your conformity assessment timelines.

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