BSI Homepage - Ireland
Contact Us
Back to menu Choose a country/region

No countries/regions found

Suggested region and language based on your location

    Your current region and language

    Submit
    Pediatrician examining a boy patient in clinic.
    • Webinar
      Medical Devices

    Navigating Article 117 — Compliance Guidance for Combination Products

    Webinar gives an overview of Art. 117, impact on combination product manufacturers that need NBOp, guidance on documentation and submission steps.

    Watch the Webinar

    Article 117 has increased the regulatory requirements

    If you manufacture combination products that need a Notified Body Opinion (NBOp), this webinar will help you:

    • Understand what Article 117 means for your next submission.

    • Learn which documents Notified Bodies expect (and why).

    • Learn how to reduce rework and regulatory queries.

    • See how the NBOp process works in practice.

    Speaker

    Hear from the expert in this webinar

    Speaker

    Theresa Jeary

    Global Head of Medicinal and Biologics, BSI

    Insights & Media

    Learn from global experts in healthcare standards

    Get Insights & Media
    Contact Us

    Let's shape your organization's future together

    Reach out and see how we can help guide you on your path to sustainable operational success.

    Get in touch
    Get in touch