Anna Polishchuk

Background

About Anna Polishchuk

Experienced Medical Technology & Regulatory Affairs Professional | IVD & MDSW Specialist | EU MDR/IVDR Compliance Expert With over 7 years of experience in the medical device and diagnostics industry, I specialize in Research & Development, Regulatory Affairs, and product lifecycle management—from early concept development to post-market surveillance. My core focus lies in In Vitro Diagnostics (IVDs) and Medical Device Software (MDSW), including point-of-care platforms and regulated software. I have a strong command of EU MDR 2017/745, IVDR 2017/746, ISO 13485, ISO 14971, and IEC 62304, with proven success in navigating complex regulatory environments. Key Competencies: Regulatory documentation & technical file preparation Risk management planning & execution Design control, verification & validation processes GSPR compliance & traceability Software development lifecycle support Performance and clinical evaluation strategy Stakeholder collaboration across R&D, QA, production, and clinical teams In parallel with industry work, I’ve contributed to EU-level research projects (e.g. Horizon 2020 SHAPES), leading regulatory-focused studies with peer-reviewed publications as first author, engaging with policymakers, manufacturers, and clinical experts across Europe. Whether supporting Notified Body submissions, mentoring cross-functional teams, or designing regulatory roadmaps, I’m passionate about driving innovation forward while ensuring patient safety and compliance.