Webinar
Medical Devices

Structured Dialogue - Achieving Predictable Reviews with BSI

This webinar shows manufacturers how to work more effectively with BSI by getting the fundamentals right early.

What will participants gain?

We’ll start with onboarding – aligning on contacts, expectations, and readiness so your review begins with fewer surprises.

Demystifying Structured Dialogue and show how to use it to resolve ambiguity upfront.
How to align goals for your regulatory pathway.
How to avoid common missteps that create downstream delays.
How to use Structured Dialogue effectively and confidently.

Speakers

Hear from the experts in this webinar

Speaker

Purvi Patel

Regulatory Lead - Medical Devices & IVDs, BSI

Speaker

Jason Butcher

Sr. Technical Specialist and Scheme Manager, Vascular Devices, BSI

BSI Insights Series: Better Together

Additional resources to support you

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.
This webinar is open to anyone working at a medical device company with an interest in gaining clarity on notified body structured dialogue and what this service allows; all are encouraged to attend regardless of function or seniority.

This includes:

Professionals in Regulatory Affairs.

Clinical and Medical Affairs.

R&D.

Quality.

Senior Leadership.

It’s particularly relevant for those involved in or responsible for regulatory strategy, clinical evidence planning, regulatory submissions, or product development, where structured dialogue and communication with your notified body are key to executive-facing 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 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 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

Register now
Structured Dialogue offers manufacturers an opportunity to better understand the Notified Body conformity assessment processes for medical devices and IVDs. It's different from scientific advice, excludes the Notified Body providing solutions to the manufacturer and does not have any impact on future certification decisions for the device under application.

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