Pujitha Gourabathini

Pujitha Gourabathini is a Quality Assurance Manager at BD Medication Management Solutions, where she leads safety and regulatory strategy for infusion pump systems across the full product lifecycle. With over a decade of experience in engineering, risk management, and standards development, she specializes in applying ISO 14971 principles and leveraging Safety Assurance Cases to strengthen risk frameworks, enable platform reuse, and drive regulatory confidence. An active contributor to global standards committees (AAMI), Pujitha helps shape policies on post market surveillance, change configuration and risk management for medical technologies. Her work bridges total product lifecycle, ensuring risk is continuously assessed and mitigated from concept through field performance. She is passionate about advancing quality culture through cross functional collaboration, systems thinking, and evidence based decision making.