Agnieszka Czajkowska

Agnieszka serves as a Senior Regulatory and Clinical Affairs Consultant at Pure Clinical. She is responsible for the qualification and classification of medical devices, verification of technical documentation in accordance with Regulation (EU) 2017/745, and preparation or updating of clinical evaluations, PMCF, PMS, and risk analyses for Class IIa, IIb, and III devices. She gained extensive experience at a Notified Body, where she was involved in technical documentation review, liaison with competent authorities, and conducting certification and surveillance audits of medical device manufacturers. Agnieszka is a Lead CE Auditor and ISO 13485 Auditor. Combining scientific expertise with regulatory practice, she supports manufacturers in effectively implementing MDR requirements and maintaining compliance of their quality systems.