Bio
A graduate of Biotechnology at Warsaw University of Technology and Nicolaus Copernicus University in Torun.
She took her first professional steps in a research and development company focused on innovative solutions used in the prevention of skin diseases, with a particular emphasis on allergic contact dermatitis. She has experience in the field of medical devices and the conformity assessment process gained at the Notified Body. Her main tasks included the assessment of technical documentation of medical devices, contact and cooperation with Competent Authorities and the conduct of certification and surveillance audits of medical device manufacturers.
CE lead auditor and ISO 13485 auditor.
At MDR Regulator, she is responsible for qualification and classification of medical devices, verification of compliance of technical documentation with Regulation (EU) 2017/745, updating or creating technical documentation, mainly clinical evaluation, PMCF, PMS or risk analysis for class IIa, IIb, III medical devices.
She likes to spend her free time reading and watching detective stories. A lover of cats, coffee and everything that contains chocolate.