Attrayee Chakraborty

Attrayee Chakraborty

Quality Systems Engineer, Analog Devices

Attrayee (Atty) Chakraborty

I am currently a Quality Systems Engineer in the Digital Healthcare division at Analog Devices, a Fortune 500 semiconductor company working in the healthcare space. I help establish compliance to US and international regulatory standards in the context of healthcare for marketing safe and effective devices in the interest of patient care. My primary field of expertise is establishing compliance for devices consisting of interaction of software and hardware in medical devices (SaMD, SiMD etc.). With a background in biotechnology and regulatory affairs, I have consulted in the past for Indian medical device startups to provide guidance to them on commercializing their products in the US and Indian market.

Outside of my 9-to-5 job, I am actively involved in contributing to standards for Artificial Intelligence in the context of healthcare (IEEE, CHAI, AIGHI, IAIGH, RAPS and SQA) and have spoken at multiple international conferences on AI integration in healthcare systems, drug misinformation, quality culture, and international regulations. I also love leading communities at RAPS, ISPE, and IEEE along with reviewing and providing feedback on upcoming standards related to AI in healthcare. You can find my blogs and publications here too.

Publications

  • Healthcare AI Governance Standard (HAIGS) 2024
    ISBN: 979-8-3507-4360-9
    Institute for AI Governance in Healthcare (IAIGH)
    Advisory board member, contributing author and reviewer

  • AI-Enabled Medical Devices In India: Opportunities And Challenges
    MedDeviceOnline
    Attrayee Chakraborty
    [website]

  • Quality as a Culture: How Can Early-Career Professionals Make an Impact?
    Quality Matters, Volume 40.2, Quality Spotlight Article; Society of Quality Assurance
    Chakraborty, A.
    [website]

  • Global AI Governance in Healthcare: A Cross-Jurisdictional Regulatory Analysis
    ArXiv.org
    Chakraborty, A., & Karhade, M.
    [pdf]

  • An in-depth look at AI enabled medical devices [White Paper]
    RegDesk Newsletter, June 2024
    Attrayee Chakraborty
    [pdf]

Invited Talks

  • Invited Speaker, Building Practical AI Validation Frameworks in the Absence of Specific Regulations (Medical Device Software Development Summit, June 2025)

  • Quality Crusaders: How Early-Career Professionals Can Revolutionize Culture and Communication (World Conference for Quality & Improvement, American Society for Quality, May 2025)

  • | Invited Speaker, Annual Conference (Society for Quality Assurance Annual Conference, April 2025)
    AI Symposium (Invited Talk)
    Topic: From boardroom discussions to procedures: how to translate AI requirements into practical procedures
    Topic: Navigating the Risk Maze: Mastering AI Compliance with ISPE GAMP and AAMI 34971
    Topic: Adapting Software Solutions for MedTech Automation and Quality: Challenges and Benefits

  • AI Governance in Healthcare: A Cross-Jurisdictional Global Analysis of Regulatory Approaches (RAPS Global Regulatory Strategy Conference, March 2025)

  • AI in 2025: where and how does it fit in a medical device product development lifecycle? (MDM West, February 2025)

  • Defining Requirements for AI enabled medical devices using a risk assessment template (Workshop)
    Consolidating the Definition of AI Under the Context of Cybersecurity to Ensure Accurate Compliance of The New Generation Medical Devices (Panel)
    Leveraging Periodic Post-Marketing Checks to Ensure Devices in Market Remain Compliant & Secure (Talk) Hands on roundtable on cybersecurity maturity assessment using amazing resources from Medical Device Innovation Consortium (MDIC) (Workshop) (Cybersecurity for Medical Devices Summit, Boston, November 2024)[link]

  • Navigating a Career in Quality in the Medical Device Space (Guest Speaker, Northeastern University, November 2024)[link]

  • Navigating Global AI Healthcare Regulations & Quality Requirements: Current Trends & Future Perspectives (Invited Speaker, MD&M Minnesota, October 2024)[link]

  • AI Regulation in Healthcare: Global Trends, Current Landscape and Future Perspectives (Invited Speaker, BMES, October 2024)
    [link]

  • AI Regulation in Healthcare: Global Trends, Current Landscape and Future Perspectives (Invited Speaker, ASQ Rochester, October 2024)[link]

  • Quality and Regulatory Requirements for AI in Medical Devices to Quality Engineers Across the US
    (Course Chair and Presenter, Quality College, Society of Quality Assurance, September 2024)

  • Global Artificial Intelligence (AI) Healthcare Regulations: Trends and Future (Invited Speaker, International Society of Pharmaceutical Engineering (ISPE) Annual Meeting, October 2024)[link] Top recognized session[[link]]{https://ispe.org/pharmaceutical-engineering/ispeak/elevate-your-career-and-stay-ahead-join-industry-leaders-2024}

  • Global AI Healthcare Regulations and Quality Requirements: Building an Effective QMS for Medical Devices
    (Invited Speaker, American Society of Quality (ASQ), Boston, October 2024)[link]

  • Quality and Regulatory Requirements for AI in Healthcare (Invited Speaker, Society of Quality Assurance, July 2024)[link]

  • AI Enabled Medical Device Regulation in India
    (Contributor, Indian Pharmaceutical Congress in partnership with Central Drugs Standard Control Organisation (CDSCO))

  • Quality and Regulatory Requirements for Medical Device Companies Using AI (Invited Speaker, RegDesk, July 2024)

  • Exploring Quality and Regulatory Considerations in AI for Healthcare: Asking the Right Questions
    (Instructor and Session Developer, Northeastern University Course INPR 0110 AI in Action: Generate Your Experience, April 2024)[link]

  • Cultivating a Culture of Quality: Insights from an Early-Career Professional in Medical Devices
    (Selected Speaker at the 40th Annual Meeting of the Society of Quality Assurance; Sole recipient of William J. Lander Sr. Memorial Scholarship, April 2024)[link]

  • Navigating Global AI Healthcare Regulations: Current Trends and Future Perspectives
    (Poster Presentation at International Society for Pharmaceutical Engineering Career Workshop, February 2024)[link]

  • National Finalist: Proposing Solutions for Combating Drug Misinformation at International Regulatory Conference,
    (Drug Information Association Student Speaker Event in Boston, MA, June 2023)[link]

Posters

  • AI/ML 510(K) Predicate Networks: A Potential for Amplification of Design-Related Recall (Poster Presentation, ISPOR Europe, November 2024)

  • AI Standards and Regulations in Healthcare to International Regulatory Bodies (FDA (US), Swissmedic (Switzerland), TGA (Australia), ANVISA (Brazil), and EMA (Europe))
    (Poster Presentation, Global Summit on Regulatory Science (GSRS), USA, September 2024)[link]

Leadership Positions

  • Advisory Board, Institute for AI Governance in Healthcare (IAIGH) (Dec 2024 - Present)
    • Contributing to the development and implementation of standards and best practices for AI governance in healthcare.
    • Collaborating with industry leaders to address regulatory, ethical, and technical challenges in AI-enabled medical devices, fostering compliance and innovation.
  • Invited Contributor, Coalition for Health AI (CHAI) (Dec 2024 - Present)
    • Invited to provide expert opinion and additions to the current version of CHAI’s Assurance Standards Guide in a regulatory context.
  • Steering Committee, ISPE GAMP Boston Chapter (Oct 2024 - Present)
    • Contributing to strategic decision-making and project oversight as a member of the Steering Committee.
  • Secretary, Regulatory Affairs Professionals Society (RAPS) Boston Chapter (Oct 2024 - Present)
    • Orchestrating comprehensive secretarial functions including meeting management, documentation, internal communications, and record-keeping while ensuring seamless information flow among members and leadership.
  • AI Collaborative Community Leader, Regulatory Affairs Professionals Society (RAPS) (June 2024 - Present)
    • Chosen as subject matter expert (SME) for leading conversations in a regulatory professional platform on regulations surrounding medical devices, artificial intelligence, and digital health.
  • Working Group, AI Global Health Initiative (AIGHI) (March 2023 - Present)
    • Active contributor in FDA-recognized collaborative community publishing whitepapers on AI systems and AI regulations.
  • International Society for Pharmaceutical Engineering (ISPE), Boston, MA (Oct 2022 - Present)
    • Joel Goldenberg Memorial Scholarship recipient (2023): National winner of scholarship worth $10,000 in recognition of being a young leader in healthcare.
    • Secretary, ISPE Northeastern University Student Chapter (2023 - 2024).
    • Volunteer recognition: Ethnocultural Diversity, Equity, and Inclusion (DEI) Committee.
    • Student Travel Grant recipient to attend ISPE Aseptic Conference, Washington D.C., 2023.
  • Working Group Member, ISPE Artificial Intelligence Community of Practice (May 2024 - Present)
    • Performing review of GAMP® Good Practice Guide: Artificial Intelligence (AI)/Machine Learning by ISPE.
  • Secretary, WG IEEE P3396 International Standard Development (May 2024 - Present)
    • P3396: Recommended Practice for Defining and Evaluating Artificial Intelligence (AI) Risk, Safety, Trustworthiness, and Responsibility.

Academic and industry review

  • Reviewer, Heart Rhythm 2025
    • Selected 44 abstracts for presentation and exhibition at Heart Rhythm 2025, the premier meeting for leaders in electrophysiology.
    • The Heart Rhythm Society (HRS) is an international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, representing professionals in over 70 countries worldwide.
  • Reviewer, 2025 IEEE International Symposium on Biomedical Imaging (ISBI) (November 2024)
    • Academic reviewer of 3 articles submitted for the 22nd IEEE International Symposium on Biomedical Imaging (ISBI 2025).
  • Reviewer, World Conference for Quality & Improvement, American Society for Quality (October 2024)
    • Graded and made decisions around accepting proposals related to quality, healthcare, supplier quality, quality tools, quality management, and quality education for the world conference.
  • Reviewer, International Conference on Biomedical and Health Informatics (June 2024 - Present)
    • Academic reviewer of articles submitted for the Institute of Electrical and Electronics Engineers Journal of Biomedical and Health Informatics (IEEE J-BHI).
    • IEEE J-BHI is ranked as one of the top three Health Information Management Journals according to H-index (137), Journal Impact Factor (2022): 7.7, and CiteScore for July 2023: 10.8.
  • Pathway Teaching Assistant for Quality Science Education (September 2024 - Present)
    • Courses: Global Regulatory and Legal Requirements of Quality (GRLR), Product Development and Validation (PV), Risk and Failure Analysis (RISK).
    • Evaluating 200+ students across North & South America, Europe, Asia, Africa, and Australia.
  • Reviewer, ADI General Technical Conference (GTC) (October 2024)
    • Graded 50 submissions, abstracts, and demo workshop proposals around healthcare technology to be accepted at the annual GTC conference.
    • The GTC is an annual technical conference running for over 45 years across 45 locations with participation from over 25,000 employees.
  • Reviewer of International Standards (Miscellaneous)
    • ISPE GAMP Good Practice Guide: Validation of AI-enabled GxP Computerized Systems — Comments accepted and determined to hold merit; will be incorporated in the next edition.
    • AAMI/ISO 11135:2014 (AAMI ST-WG01: Industrial EO Sterilization Working Group) — Comments accepted and determined to hold merit; will be incorporated in the next edition.
    • Safe and Responsible Artificial Intelligence in Health Care (Australian Government: Department of Health and Aged Healthcare) — Comments published on the official website.[link]
    • Healthcare AI Governance Standard: Institute for AI Governance in Healthcare — Comments accepted with an invitation to rewrite sections of the standard.
  • Reviewer for Course Syllabus, Emory University/Georgia Tech (November 2024 - Present)
    • Course: Master of Science Biomedical Innovation and Development – Advanced Therapeutics.
    • Invited to review syllabus and provide inputs for the Masters program in regulatory and quality.

Features

  • Cybersecurity Medical Devices [link]

  • Attrayee Chakraborty - Cybersecurity Medical Devices [link]

  • Regulatory Trends for AI in the United States & Beyond [link]

  • Attrayee Chakraborty - Northeastern University College of Professional Studies [link]

  • Op-ed: Lessons from an International Student in Regulatory Affairs [link]

  • Transformative Impact: My Journey with ISPE from Aspiring Student to Emerging Professional [link]

  • From Concept to Care: Navigating Across the Regulatory Framework in HealthTech - E05 - The Doc Suit [link]

Awards

ADI Silver Impact Award

  • Company award for exceptional and consistent contributions to ADI.

Quality Rookie of the Year Award, 2025

  • Industry award by Quality Magazine [\link](https://www.qualitymag.com/nominate-quality-rookie-of-the-year) to recognize an individual with one to five years of experience in the industry who has contributed to the quality profession.

Contact

Work Email: attrayee.chakraborty@analog.com
Personal Email: attybird@gmail.com