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LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls

Summary

“Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Pujitha Gourabathini, Quality Assurance and Risk Management leader at Becton Dickinson, to explore one of the most persistent challenges in MedTech: effectively integrating risk management with design controls.

Pujitha shares practical, experience-based insights on why risk files often become disconnected from design inputs, verification strategies, and sustaining…

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