Dr. Sabine Nieba
Partner & COO
Dr. Sabine Nieba is an experienced expert in regulatory affairs and quality management in the field of medical devices. As a biochemist by training, she is used to be very solution-oriented. Sabine has worked in leading positions in device development and regulatory/quality in the medical device industry and as a regulatory consultant focusing on medical device software, electrical medical devices, drug delivery devices and IVDs. Successfully leading multidisciplinary project teams was a key factor to her success and customer satisfaction. She also worked as a technical file reviewer for a swiss notified body and was involved in the joint audit for the designation under the MDR.
Sabine's current projects include:
defining regulatory strategies or transition strategies for medical devices (MDD/MDR class I to III incl. software and substance based products) and in-vitro diagnostic devices under the new European regulations
setting up IEC 62304 compliant software lifecycle processes
supporting and reviewing clinical evaluations for medical devices and performance evaluations for IVDs
providing expert regulatory opinions for submissions in different countries
preparing technical documentation for submission to competent authorities and notified bodies and answer their questions
CV upon request