QbD Group
    点播网络研讨会

    From Paper to Practice: Technical Documentation Essentials for Medical Device Software

    Watch our webinar to gain practical insights on crafting essential technical documentation (TD) with confidence.

    随时观看
    60 分钟
    Medical Devices
    Chinese

    nce.

    We’ll take you step-by-step through interpreting MDR requirements, choosing the right accredited Notified Body, and navigating the qualification and classification process—all with a focus on your software’s Intended Purpose.

    Don’t miss this opportunity to ensure your documentation is not just compliant, but also clear and comprehensive.

    What you'll learn

    • Practical guidance for creating comprehensive TD for MDSW.
    • Interpret MDR for MDSW and navigate its unique requirements.
    • Types of software documentation needed in TD.
    • Implement MDR-compliant SOPs in your QMS.
    • Best practices for setting up UDI requirements.
    • Manage post-market surveillance for MDSW.
    • Handle software releases and notify Notified Bodies effectively.

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