Attrayee Chakraborty
Quality System Engineer Independent Expert
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. She is also a working member of AI Global Health Initiative (AIGHI) AI in Operations team (an FDA-recognized collaborative) and individual contributor at IEEE P3396 standards (Recommended Practice for Defining and Evaluating AI Risk, Safety, Trustworthiness, and Responsibility). Attrayee is recognized as an AI community leader by the Regulatory Affairs Professional Society (RAPS) and is a recipient of the RAPS Rising Star Award and Quality Rookie Award.
Seminars
A practical, end-to-end walkthrough of how regulated medical device software is actually built, controlled, and monitored in the real world. Participants will move chronologically through the product lifecycle, connecting design controls, risk management, and post-market activities into one continuous system
- Walk through the full software lifecycle, from intended use and design controls to risk management, V&V, change control, and post market surveillances show how each stage connects and shapes regulatory expectations
- Use hands-on exercises and scenario-based discussions to practice drafting design inputs, risk tables, and change assessments while exploring how AI, automation, and real-world data influence control strategies
- Give attendees a clear mental model of an end-to-end lifecycle, practical examples of strong documentation and traceability, and confidence in building processes where quality and compliance are integrated throughout development
- Extend these principles to ML/AI-enabled devices, demonstrating how design controls, risk management, validation, monitoring, and change management are adapted for adaptive algorithms and continuously learning systems
Closing Question: How do you apply design controls & do you even apply design controls to non-medical device software?
