Marina Daineko is a Senior Compliance Assurance Manager at EPAM Systems with over 10 years of experience in medical device regulation, biocompatibility, and compliance for global Life Sciences & Healthcare organizations. She advises international clients on regulatory strategy, risk management, and audit readiness for medical devices and regulated software, with hands-on experience across EU MDR, FDA, GxP, ISO 13485, IEC 62304, and ISO 14971. Marina is also a recognized authority in ISO 10993-1–based biological evaluation, supporting remediation, safety justification, and evidence-based decision-making across the product life cycle, including integration of post-market and chemical characterization data into biological risk management across the world. She is a frequent international speaker and trainer, holds an MSc in Analytical Chemistry, has authored 15+ peer-reviewed publications, and holds two patents. Her work has been recognized through a Women in Tech Award nomination (2023).