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.
Learn the role of the UK Responsible Person (UKRP) for medical devices and IVDs, and how they ensure compliance with MHRA requirements in Great Britain.
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Learn how the Swiss Authorised Representative (CH-REP) ensures compliance with MedDO and IvDO requirements for medical devices and IVDs in Switzerland.
阅读更多Descubre cómo el Representante Autorizado Suizo (CH-REP) asegura el cumplimiento de los requisitos de MedDO e IvDO para los productos sanitarios y los productos sanitarios para diagnóstico in vitro (IVD) en Suiza.
阅读更多Descubre cómo el Representante Autorizado Suizo (CH-REP) garantiza el cumplimiento de los requisitos de MedDO e IvDO para los productos sanitarios y los productos sanitarios para diagnóstico in vitro (IVD) en Suiza.
阅读更多Descubre cómo el Representante Autorizado Suizo (CH-REP) garantiza el cumplimiento de los requisitos de MedDO e IvDO para productos sanitarios y DIV en Suiza.
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Learn why an EU Authorised Representative is essential for MDR and IVDR compliance — and how QbD RepS BV helps non-EU manufacturers enter the EU market with confidence.
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¿No sabes si tu IVD requiere un representante legal según el IVDR? Aprende la diferencia entre uso interno, estudios de rendimiento y diagnóstico complementario.
阅读更多¿No estás seguro de si tu IVD requiere un representante legal según el IVDR? Aprende la diferencia entre uso interno, estudios de rendimiento y diagnósticos complementarios.
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Aprende a integrar los IVD en los ensayos clínicos globales cumpliendo los requisitos de la IVDR y la CTR. Consejos prácticos, casos reales y experiencia QbD.
阅读更多Aprende a integrar los IVD en los ensayos clínicos globales cumpliendo con los requisitos de la IVDR y la CTR. Consejos prácticos, casos reales y experiencia en QbD.
阅读更多Learn how to integrate IVDs into global clinical trials while meeting IVDR and CTR requirements. Practical tips, real-world cases, and QbD expertise.
阅读更多Unsure whether your IVD requires a legal representative under the IVDR? Learn the difference between in-house use, performance studies, and companion diagnostics.
阅读更多Aprende a integrar los productos sanitarios para diagnóstico in vitro (IVD) en los ensayos clínicos globales, cumpliendo con los requisitos del IVDR y el CTR. Consejos prácticos, casos reales y experiencia en QbD.
阅读更多¿No estás seguro de si tu IVD requiere un representante legal según el IVDR? Aprende la diferencia entre uso interno, estudios de rendimiento y diagnósticos complementarios.
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Annex XIV performance study applications often face delays. Discover the 5 most common causes and how to avoid them for smoother IVDR compliance.
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IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.
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La Comisión Europea propone ampliar los plazos de cumplimiento del nuevo Reglamento sobre productos sanitarios para diagnóstico in vitro (IVDR). Este artículo analiza los motivos de la prórroga y lo que significa para los fabricantes.
阅读更多Los fabricantes de IVD deben alinear ISO 13485 e IVDR para un Sistema de Gestión de Calidad conforme. Este artículo explora las consideraciones clave para armonizar estos marcos.
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Compliance with Annex XIV is essential for certain IVD performance studies under the IVDR. Learn when these requirements apply, what documentation is needed, and how to navigate the regulatory process effectively.
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Discover why usability testing is essential for compliance and safety in Near-Patient and self-testing devices under the IVDR. Learn key guidelines, study designs, and tips for successful usability evaluations.
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Discover how to define a clinical performance strategy for IVD devices under IVDR. Learn key steps from intended purpose to performance data assessment.
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Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we'll explore the role of Clinical Performance in a smooth IVDR submission.
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了解根据 IVDR 和 ISO 20916:2024 开展 IVD 临床表现研究的基本要求。
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New EU regulations challenge IVD manufacturers with stricter PMS and PMPF requirements. Learn why prioritizing them is crucial under IVDR.
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Discover why clinical evidence is essential for IVDR compliance in IVDs and learn about the common challenges manufacturers face.
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Even with the European Commission's proposal for extending the transitional period for IVDs, manufacturers should start building compliant Technical Documentation now.
阅读更多The European Commission proposes extending IVDR compliance deadlines. Discover why the extension is needed and what it means for IVD manufacturers.
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Play IVDR Transitional Extension: Why full speed ahead is still the best strategy \| QbD Group AI-generated audio 3:32 IVDR transitional extension: Why still move ahead? from QbD Group on Vimeo  Playing in picture-in-picture [](https://vimeo.com/qbdgroup?fl=pl&fe=po) IVDR transitional extension: Why still move ahead? [QbD Group](https://vimeo.com/qbdgroup?fl=pl&fe=by)
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