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Bianca Lutters

Head of Clinical Operations
QServe Group

Bianca is currently head of Clinical Operations at Qserve, leading the CRO and the clinical writing team. In addition, she supports customers with a focus on clinical and regulatory. Bianca has over 15 years experience in the medical devices field. She spent ten years Notified Bodies (DEKRA and BSI). Afterwards, Bianca spent five as Director Regulatory and Quality in a start-up company with high-risk biodegradable cardiovascular products. She has been involved in defining the clinical and regulatory strategy and supporting clinical studies for these products in both Europe and the US. Bianca holds a Master degree in medical biology and a PhD in biochemistry, more specifically in thrombosis and haemostasis.

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