QbD Group
    Annex XIV Applications: Avoid These 5 Common Delays

    Annex XIV Applications: Avoid These 5 Common Delays

    Annex XIV performance study applications often face delays. Discover the 5 most common causes and how to avoid them for smoother IVDR compliance.

    September 4, 2025· Updated Mar 10, 20260 min read

    About the Author

    Kirsten Van Garsse
    Kirsten Van Garsse

    MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs

    With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.

    Regulatory Affairs services

    Navigate Regulatory Complexity with Confidence

    Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.

    Read more
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