Nilay Shah

The thesis work is based on the design and implementation of a novel technical documentation architecture according to IVDR and to the new risk management standard (ISO 14971:2019) with special focus on performance evaluation, post-market surveillance and UDI.

The internship work is focused on the evaluation of the design and development procedure for a novel IVD medical device used for molecular diagnostic testing with regard to international regulatory requirements with special focus on MDSAP (Medical Device Single Audit Program), EN ISO 13485:2016, 21 CFR 820.30 (FDA), RDC 16 (Brazil).

Risk management system, quality management system, Medical Device Directive (MDR), In Vitro Medical Device Directive (IVDR), usability of medical devices, software Validation, ISO 13485, ISO 14971.

Regulatory Affairs, Quality management in healthcare system