Please join us on Tuesday May 26, 2026 at Lenzi's Catering & Function Facility in Dracut, MA from 5:30 PM to 8:00 PM
This is our first in-person event for 2026. This is a joint meeting of Granite State and Merrimack Valley ASQ sections. We are excited to bring everyone out for networking and an exciting topic. Please register early!
Our speaker, Attrayee (Atty) Chakraborty, will present “Case Study: Engineering Safety for AIEnabled Medical Applications”.
Topic
The FDA has introduced the Early Alerts program and issued warning letters for AI device misclassification, signaling heightened enforcement in this area. While FDA guidance focuses on risk elements to be included in a submission, this talk will emphasize the "how" to create and implement a comprehensive risk management file for an AI-enabled medical device— comprising a risk management plan, risk assessment, and risk management report.
We will demonstrate how Failure Modes and Effects Analysis (FMEA) can systematically identify, assess, and mitigate AI-specific risks such as algorithmic bias, data drift, and unintended behaviors, illustrated through a case study of an AI-enabled medical device. Attendees will learn how FMEA aligns with ISO 1497/AAMI 34971 and engineer safety through the total product lifecycle (TPLC). Drawing on FDA’s latest guidance on AI-enabled device software functions and lifecycle management, we highlight the need to integrate risk management, data quality assurance, algorithm transparency, and post-market monitoring across the total product lifecycle, enabling robust compliance and patient safety.
Biography
Attrayee (Atty) Chakraborty is an award-winning Quality Systems Engineer at a Digital Healthcare division. Attrayee has previously spoken on AI integration in healthcare systems, drug misinformation, quality culture, and international regulations at 30+ national and international conferences and workshops. She is the President and a member of the Board of Directors at the Boston Congress of Public Health, a global accelerator for emerging public health talent. Atty serves as the Vice Chair for Newsletters and Publications at the Medical Device Division at the American Society for Quality (ASQ). Atty is recognized as an AI community leader by the Regulatory Affairs Professional Society (RAPS) and is a recipient of the RAPS Rising Star Award (2025) and Quality Rookie Award (2025) for her consistent contributions to the quality and regulatory space.
Registration
Registration is through Granite State's Member Planet account. New members with letters from our membership chair may attend the dinner portion for free. Please register as early as possible as we need to let the venue know of our final count within a week of the event.
Click the link below, paste it in your browser, or scan the QR code.
https://mp.gg/ssxvwgrbo
Attending:
Please feel free to bring colleagues to the meeting; it is open to all. You do not need to be a member of either section to attend.
Meeting Date and Time
Tuesday May 26, 2026
Networking from 5:30 pm to 6:00 pm
Dinner from 6:00 pm to 7:00 pm
The presentation is from 7:00 pm to 8:00 pm
Cost is $30.00 with the dinner option, free without dinner
Meeting Location
Lenzi's Catering & Function Facility
810 Merrimack Ave
Dracut, MA 01826