Pujitha P Gourabathini

Pujitha Gourabathini is a Quality Assurance Manager at BD Medical, where she leads global safety and regulatory initiatives across infusion and insulin delivery platforms.

With deep expertise in biomedical engineering, risk management, and regulatory strategy, she architects safety cases that withstand the scrutiny of FDA, ISO, and EU MDR standards, ensuring transformative safety culture.As a Six Sigma Black Belt, CQE, and PMP-certified leader, Pujitha brings precision, systems thinking, and cross-functional leadership to every evaluation. She is an active contributor to AAMI standards committees, a published scholar in medical device safety assurance, and a peer reviewer for technical journals spanning engineering, healthcare, and emerging technologies like AI and ML.

Her judging and review work is grounded in real-world applicability, technical rigor, and institutional impact that bridges disciplines and drives meaningful societal change. She brings a balanced perspective that combines academic depth with practical insight, ensuring that each evaluation not only meets the highest standards of excellence but also reflects relevance, integrity, and long-term value.