Anette Kristiansen

With a robust background entrenched in the medical device sector, I possess a profound comprehension of both clinical procedures and regulatory frameworks. Throughout my professional journey, I have gained a diverse range of experience in the medical device sector. Starting as a nurse, I worked with medical devices and IVDR devices from the front lines of patient care. I furthered my knowledge and expertise by working as a Research Nurse, conducting my own research alongside my clinical duties.

A brief visit to medical device sales offered invaluable insights into the industry’s commercial aspects before I transitioned to a pivotal role as a Senior Principal Advisor at a Contract Research Organization (CRO). I transitioned into a role as a Senior Principal Advisor for a Contract Research Organization (CRO). In this position, I provided guidance and oversight to medical device and IVDR companies in matters of clinical and regulatory compliance.

Currently, I lead the Clinical & Scientific Affairs Team at Neurescue. In this role, I have successfully developed and implemented a comprehensive clinical and regulatory strategy to achieve CE mark conformity and compliance with US regulatory requirements. I have effectively identified the data needed for market approvals and implemented these in our documentation and clinical investigations within emergency research of a class III device.