Creating technical documentations for medical devices:- Conceptualization and actual writing of clinical and biological evaluation plans (CEP, BEP) and clinical and biological evaluation reports (CER, BER) according to - EU Regulation 2017/745 (MDR) - MEDDEV 2.7/1 rev 4. - EN ISO 10993-1:2020 standards (biological evaluation of medical devices)Conceptualization and actual writing Clinical Investigation Plans (CIP) and related documents for medical devices following the - EN ISO 14155:2020 (Clinical investigation of medical devices for human subjects - Good clinical practice)

Validating the RT-qPCR results from SARS-CoV-2 mass testing:- Extracting raw data from thermal cycler- Allocating fluorescence channels to raw data- Validation of runs e.g: - Quality check of positive controls using Cq values - Check positive, negative and non-template controls - Check orientation - Check range, e.g. all sample lots are on the plate- Decide on uncertain results by visual inspection of reaction curves- Write PowerShell scripts for automated data retrieval- Compiling daily statistics- Reporting to Technical Officer, handling special requests- Identify patterns in failed runs (eg. human or machine related errors)- eLIMS interactions

Planning and carrying out various research and training related tasks.