WEBINAR 2 – Structured Dialogue – Achieving Predictable Reviews with BSI

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.

Attendees will leave with:

A clear, practical playbook for working with BSI from day one, including how to align goals for your regulatory pathway, what to bring to early conversations, and how to avoid common missteps that create downstream delays.

You’ll also learn how to use Structured Dialogue effectively and confidently while resolving any ambiguity upfront and reduce avoidable review cycles to protect your submission plans and certification timelines.

This is the second 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.