Quality Systems and Risk Management with Megan Graham

Our guest is Ms. Megan Graham who is an experienced medical software quality and regulatory consultant, focusing on digital health. Ms. Graham also serves on a number of international standards committees including most recently AAMI SW WG-10 Cloud Computing. She is also an adjunct faculty member at the University of Minnesota where she teaches in the Master of Science Software Engineering Program. This interview was recorded Dec 14, 2023.

Further Reading:

Good Machine Learning Practice for Medical Device Development: Guiding Principles (ÒGMLPÓ). October 2021, Food & Drug Administration, Health Canada, and Medicines and Healthcare Products Regulatory Agency. Available from: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

ISO 13485:2016, Medical devices – Quality management systems – requirements for regulatory purposes. March 2016, International Organization for Standardization. Available from : https://www.iso.org/standard/59752.html

ISO 14971:2019, Medical devices – Application of risk management to medical devices. December 2019, International Organization for Standardization. Available from: https://www.iso.org/standard/72704.html

AAMI TIR 34971:2023, Application Of ISO 14971 To Machine Learning In Artificial IntelligenceÑGuide. March 2023, Association for the Advancement of Medical Instrumentation. Available from: https://doi.org/10.2345/9781570208669.ch1

NIST Risk Management Framework. National Institute of Standards and Technology. Available from: https://csrc.nist.gov/projects/risk-management

NIST Secure Product Development Framework. National Institute of Standards and Technology. Available from: https://csrc.nist.gov/projects/ssdf

Overgaard SM, Graham MG, Brereton T, Pencina MJ, Halamka JD, Vidal DE, Economou-Zavlanos NJ. Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions. NPJ Digit Med. Nov 25;6(1):218. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676432/

This interview is also available in video form on YouTube: https://youtu.be/POd0LQ80t4w