Romania, Netherlands (Notification Bodies).
Certificator of “the Uber in Teledermatology” – Skinvision MD.
Facilitator for Digital Health(CARE) businesses providing support in Quality and Regulatory Affairs. Addressing challenges posed by European market and legislation, offering consultancy on the Romanian (local) and EU ecosystem related to medical devices and software, gadgets, mobile medtech. Quality protection and governance are the focus of my activities performed as an internal auditor and compliance lead for SMEs. Experienced in both waterfall and Agile models while designing and testing products, processes and procedures for innovative enterprises launched on global market.
Areas of regulatory/reimbursement support:
My expertise consists in EC certification processes of mHealth apps, medical devices and health informations systems.
Among activities performed are: identification, analysis, verification and validation of essential requirements, documentation and follow-up processes, versioning and change control, plans of approach, EU technical files reviews, IU and standards curation, QMS, RM, customer (re)presentations to Romanian regulatory authorities, negotiating to NB for marketing authorisations.