Pujitha Gourabathini
Quality Assurance Manager
Pujitha Gourabathini is a Quality Assurance Manager specializing in medical device safety, risk management, and regulatory compliance. She leads cross-functional initiatives to ensure products meet global standards, including ISO 14971, IEC 62304, and FDA QSR, with a focus on hazard analysis, risk-benefit evaluation, and mitigation strategies.
Her expertise spans the full lifecycle of medical devices, where she drives robust risk management. Pujitha is known for her methodical approach, strategic communication, and commitment to advancing patient safety through evidence-based quality systems.
DAY 2: March 6th, 2026
SESSION: Cumulative E&L Effects and Combined Risk Assessment
◆ Why cumulative exposure matters in biological safety: How cumulative and combined chemical exposures across materials, components, and use durations influence overall patient risk, and why traditional single source E&L assessments don’t fully capture that picture.
◆ Bridging chemistry, toxicology, and device risk: A practical, ISO aligned approach for integrating chemical characterization, toxicological thresholds, and clinical use conditions into a unified cumulative exposure narrative.
◆ Methods for combined risk assessment: Strategies for evaluating additive, synergistic, or repeated use E&L effects across multi material systems, drug contact pathways, and complex delivery platforms.
◆ Operationalizing cumulative E&L thinking: How manufacturers can embed cumulative exposure considerations into risk management files, biological evaluation plans, and regulatory ready documentation that withstands scrutiny.
