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    • 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.

    Article 117 has increased the regulatory requirements

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

    • What is Article 117.

    • The process for DDC manufacturers.

    • Documentation requirements.

    • Output of the process.

    Speaker

    Hear from the expert in this webinar

    Dr Jennifer Durrant, Global Head of Medicinal and Biologics, BSI

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