Wioletta Kozlowska

Supporting MedDev submissions for EU market certification and evaluating comprehensive technical documentation. Preparing and implementing eQMS systems compliant with ISO 13485, MDR, and IVDR standards. Managing change processes for existing legal manufacturing contracts to ensure regulatory alignment.

Project management of clinical investigations for Class I medical devices (breast support for radiotherapy), ensuring documentation compliance with EU MDR, FDA 21 CFR, and Swiss MedDO regulations. Focus on strategic planning, data management protocols, and ethics committee submissions. Preparation of Ethics Committee submission documents including Clinical Investigation Plan (CIP), Case Report Forms (CRFs), and Informed Consent Forms (ICF).

Supporting preparation for CE certification.

• Contributed to the STELLA project, designing a low‑cost radiotherapy knowledge‑transfer framework for LMICs