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

Dr. Sabine Nieba on LinkedIn

CV upon request