
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.
Speaked About
March 5, 2026
Gain insights into the latest techniques for testing and analyzing Extractables and Leachables. Access full recordings of all sessions from the two-day event.
Upcoming
DAY 1: March 5th, 2025
SESSION: Cumulative E&L Effects and Combined Risk Assessment
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