What is the webinar about?
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.
Who should attend?
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.
What will participants gain?
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.
Speakers
