dr Ela Piątkowska
Stanowisko: ekspertka ds. regulacji i zarządzania projektami w sektorze ochrony zdrowia, właścicielka, Ella M Elżbieta Piątkowska (JDG), Lębork
Ph.D. in Biochemistry with strong expertise in business development, commercialization, regulatory affairs, and healthcare & med-tech investment. Expert in commercial partnerships for AI deep tech, med tech, and SaaS companies. Hands-on experience in analytical chemistry, development of medical devices, in-vitro diagnostic tests, and biologics for immuno-oncology and cardiovascular diseases. Large network of academic and healthcare stakeholders (HCPs, CROs, CDMOs, reg. consultants, biotech and pharma)
Regulatory Experience. Implementation and management of QMS system according to ISO 13485 for medical and in-vitro devices. Preparation of technical documentation according to MDR (2017/745)/IVDR (2017/746) – risk management, human factor studies. clinical protocol preparations. Preparation of technical documentation for FDA - 510k, De Novo, and Breakthrough submissions. Certification of laboratories according to - ISO 17025, GMP
Healthcare Project Management. Management of project milestones, KOLs interaction, assistance with business development and partnerships. Medical communications: medical writing, communication strategy for healthcare and med tech companies