Bianca Lutters

Head of Clinical Affairs and Principal Consultant at Qserve Group

Speaker

Bianca is currently head of Clinical Affairs at Qserve, leading the CRO and the clinical writing team. In addition, she supports customers with a focus on clinical and regulatory. Bianca has 20 years of 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.