Pujitha
Gourabathini
Quality Assurance Manager at Becton Dickinson and Company
"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
Wed May 13 - 5:50 PM EDT/New York (See in local time)
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05/13/2026 5:50 PM
05/13/2026 06:10 PM
America/New_York
#WTGC2026
"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
#WTGC2026
"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
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"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
"AI in the Loop: Reimagining Medical Product Safety and Manufacturing"
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Session: AI in the Loop: Reimagining Medical Product Safety and Manufacturing
As AI and machine learning become embedded in the lifecycle of medical products from design and manufacturing to post-market surveillance, the traditional paradigms of safety assurance and regulatory compliance are being redefined. This session explores how “AI in the loop” can be harnessed to enhance product quality, accelerate root cause analysis, and enable predictive risk management in highly regulated environments.Drawing from real-world experience in biomedical safety and regulatory strategy, this talk will examine:
1. How AI-enabled systems can support closed-loop safety monitoring and continuous improvement
2. The evolving role of quality and risk professionals in validating and governing AI tools
3. Practical frameworks for integrating AI into safety cases and quality management systems
4. Strategies for aligning AI innovation with ISO 14971, IEC 62304, and FDA expectations
Attendees will gain insights into how to lead responsibly in this new era, where human oversight, regulatory foresight, and algorithmic intelligence must work in harmony to protect patients and advance innovation.
Key Takeaways
- Understand how AI and machine learning are transforming medical product development and safety assurance in the life sciences industry.
- Learn practical strategies for integrating AI into risk management workflows while maintaining regulatory compliance and patient safety.
- Explore real-world examples of how digital tools and predictive analytics are accelerating innovation across infusion and insulin delivery platforms.
- Discover how cross-functional teams can be empowered to lead responsibly through AI-driven transformation in regulated environments.
- Gain insights into building a proactive quality culture that balances cutting-edge technology with trust, transparency, and resilience.
Bio
Pujitha Gourabathini is a Quality Assurance Manager at BD Medical, where she leads cross-functional teams in biomedical safety assurance, regulatory strategy, and risk management for infusion and insulin delivery platforms. With deep expertise in ISO 14971, IEC 62304, and FDA QSR, she architects safety cases for complex medical systems and contributes to global standards shaping the future of healthcare technology.Pujitha is passionate about bridging AI innovation with regulatory rigor. Her work explores how “AI in the loop” can enhance product safety, streamline manufacturing, and support real-time decision-making in highly regulated environments. She also mentors emerging professionals, judges STEM awards, and advocates for women’s leadership in science and technology.
