BSI Insights Series: Better Together

Our three‑part webinar series is designed to help medical device manufacturers navigate EU MDR & IVDR with confidence and predictability.

Ideal for regulatory, clinical, R&D, quality, and senior leaders

These sessions translate complex requirements into practical strategies for innovation, clearer reviews, and smoother certification.

Clearer alignment and early collaboration with BSI to support the Breakthrough Device (BtX) pathway.
Effective use of Structured Dialogue.
Interactive review models that reduce rework and protect timelines.

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.

Watch the Webinar
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.

Tuesday 16 June - 16:00 BST

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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.

Tuesday 23 June - 16:00 BST

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