Alexandra- Maria Tautan, MSc
Alexandra is part of the Regulatory Active Devices Group, her area of expertise being UDI compliance. As a Qserve Consultant, she was involved in writing regulatory strategies, in projects ensuring compliance for software and other active medical devices in EU and the US, in helping companies with building and maintaining their quality management system.
Prior to joining Qserve, Alexandra worked in R&D as a Biomedical Application Developer focusing on wearable healthcare technology at Imec/Holst Centre, located on the High Tech Campus Eindhoven. Her responsibilities included algorithm prototyping, performing software and hardware quality tests and conducting data collection for research and development purposes.The technologies she is familiar with from her studies and work include mesh nebulizers user tests, recording and digital processing of ECG (electrocardiogram), EEG (electroencephalogram), PPG (photoplethysmography) and EDA (electrodermal activity) signals, processing of lung CT and MRI images.
The key expertise areas of Alexandra-Maria include:
UDI compliance for USA and EU MDR
Compliance with IEC 62304, ISO 13485
Class I and Class IIa active medical devices
Medical device classifications and regulatory strategies
Alexandra has a Bachelor degree in Applied Electronics from POLITEHNICA University of Bucharest and a Master degree in Biomedical Engineering from Delft University of Technology.
Alexandra-Maria about Qserve:
“I like the diversity of the work and finding tailored solutions that combine both my technical and regulatory knowledge. Need help with UDI compliance? Let us know and I am sure we can find a solution together".