Bianca Lutters

Bianca Lutters

Regulatory Affairs Expert
Senior Consultant

Bianca has more than 15 years experience in the medical devices field, ten of which have been spent at two major Notified Bodies, DEKRA and BSI. 

In her time working for Notified Bodies, Bianca assessed many design dossiers and technical files including (cardio)vascular devices, drug-device combinations, absorb-able devices and devices containing animal tissue. In addition, as a lead-auditor, she has conducted many QMS audits, including several unannounced audits, for a wide-range of manufacturers and distributors in the MedTech sector.

The key expertise areas of Bianca
  • Expert advice on clinical and regulatory strategy for medical devices in Europe and US
  • Expert advice on the interpretation and implementation of the EU Medical Device Regulation
  • Expert advice on regulatory submissions for non-active devices
  • Trainer for medical device regulatory subjects and Quality  management
  • Documentation and review of Design History Files, Device  Master Records, Product Design Dossiers and Technical Files
  • Write and review regulatory clinical study documentation, such as Investigational Device Exemption and Investigator Brochure
  • Review of the full set of clinical study documentation and support in interactions with Competent Authorities and Ethics Committees
  • Expert advice on Notified Body selection and interaction
  • Expert advice and support of interactions with the US FDA
  • Design and implementation, monitoring and maintenance of Quality Management Systems according to ISO 13485
  • Lead-auditor. Conduct quality system and regulatory focused audits, including internal - and supplier audits.
  • Interim Management for Quality Assurance and Regulatory Affairs Management positions

Before Qserve

The last five years Bianca spent as Director Regulatory and Quality in a start-up company with high-risk biodegradable cardiovascular products. She was responsible for Regula-tory and Quality and has been involved in defining the clinical and regulatory strategy for these products for both Europe and the US. In addition, Bianca has been involved in obtaining approval and managing clinical studies in Europe, Asia 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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