Attrayee Chakraborty
Attrayee Chakraborty MS MSc CQSP, is a senior quality systems engineer at Analog Devices. She has experience in quality systems and regulatory affairs in medical devices, with a focus on quality management systems and AI regulation, she is also the recipient of the RAPS Rising Star Award (2025), Quality Rookie of the Year Award (2025) and AAMI Young Professional Award (2026). She can be reached at attybird@gmail.com.
JournalFrom gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Rapid advances in AI, software and drug discovery are reshaping regulation. This article challenges the view that regulation hinders innovation, framing it as a collaborative, risk-based partnership with real-world examples from AI diagnostics, in silico methods and medical device tools.