Pujitha Priyadarshini

Background

About Pujitha Priyadarshini

Quality & Risk Management Champion | Medical Device Safety Strategist | Standards Contributor | CQE | PMP Driving lifecycle safety, regulatory excellence, and global compliance across complex medical technologies. As a Quality Assurance Manager at BD, I lead structured safety case development, risk management, and cross-functional quality culture initiatives. Expert in ISO 14971, IEC 62304, FDA QSR, EU MDR, with deep experience in Risk Management, CAPA/NCR resolution, remediation, and inspection readiness. Skilled in Design & Process FMEA, Fault Tree Analysis, and Use Error Analysis, with a track record of authoring Final Risk Management Reports that withstand global scrutiny. Active contributor to AAMI standards committees and peer reviewer across disciplines, with a passion for elevating safety, equity, and innovation in healthcare. I mentor teams, judge technical awards, and speak on embedding safety culture into product lifecycle, and about digital transformation. Let’s connect if you’re advancing medical device safety, shaping global standards, or building resilient quality systems.