Medical Device Expert and Founder of Med Quality with more than 10 years of experience in auditing, certification, quality management system implementation, and technical documentation development.

Having conducted over 200 audits of medical device manufacturers, I currently serve as an auditor for a conformity assessment body and hold two higher education degrees in Quality Management Systems and Pharmaceutical Biotechnology.

I help medical device manufacturers successfully enter the market, comply with the requirements of the Ukrainian Technical Regulations and the EU Medical Device Regulation (MDR), and confidently pass market surveillance inspections. My practical experience includes working with manufacturers of prosthetic and orthotic devices, custom-made medical devices (including 3D-printed products), as well as international companies entering the Ukrainian market.

My areas of expertise include ISO 13485, clinical evaluation, risk management, and the development of practical quality management systems that not only meet regulatory requirements but also withstand real-world audits rather than existing solely on paper.