Sandra Bugler leads the clinical affairs team at NSF and has devoted her professional time to clinical evaluations, clinical investigations and PMCF activities. She has successfully implemented the EU Medical Device Regulation (MDR) 2017/745, the MEDDEV 2.7/1 rev. 4 and relevant MDCG guidelines during her career.
Upon completing her Master of Science in medical engineering, Sandra worked in regulatory and clinical affairs and gained experience in implementing processes and approving medical devices. Sandra oversees the local implementation of the ISO 9001 quality management system in NSF’s Hamburg office. Her expertise also includes clinical affairs training for TÜV SÜD and speaking at conferences.
Sandra holds an M.Sc. in medical engineering from the University of Lübeck in Germany.
Areas of Expertise:
- Clinical Evaluation
- Clinical Investigation
- Performance Evaluation
- Post-Market Clinical Follow-Up
- Post-Market Surveillance
- Quality Management Systems
- EU Medical Device Regulation (MDR)