On-Demand Webinar: Software Interface Design for Medical Devices



International Electrotechnical Commission. ANSI/AAMI/IEC 62304 2006 & A1:2016: Medical device software--Software life cycle processes 2016

Faulkner, Laura. “Beyond the five-user assumption: Benefits of increased sample sizes in usability testing.” Behavior Research Methods, Instruments, & Computers. 2003

IMDRF SaMD Working Group. Software as a Medical Device (SaMD): Key Definitions. International Medical Device Regulators Forum. 9 December 2013

Lin, Laura, et al. “Patient Safety, Potential Adverse Drug Events, and Medical Device Design: A Human Factors  Engineering Approach.” Journal of Biomedical Informatics 2001

Lin, Laura. “Human Error in Patient-Controlled Analgesia: Incident Reports and Experimental Evaluation.” Proceedings of the Human Factors and Ergonomics Society Annual Meeting. 1998

Makary, Martin A, and  Daniel, Michael. “Medical error--the third leading cause of death in the US” British Medical Journal (BMJ), 2016

Patterson, Patricia A.  and North, Robert A. “A Sneak Preview of FDA's Human Factors Standard.” Qmed. Medical Device and Diagnostic Industry. 2010.

Speer, John. “The Ultimate Guide to Design Controls for Medical Device Companies.” GreenLight Guru: (eBook) 2018

Stewart, Patrick J., et al. Software as a Medical Device (SAMD): Clinical Evaluation – Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2017

Story, Mary Folette, PhD. “The FDA Perspective on Human Factors in Medical Device Software Development.” IQPC Software Design for Medical Devices Europe. 2012.

U.S. Food, Drug Administration, Center for Devices, Radiological Health, Office of Compliance Division of Analysis, and Program Operations. “Medical Device Recall Report FY2003 to FY2012.”  2013

U.S. Food, Drug Administration, Code of Federal Regulations. Title 21, Volume 8. Revised as of April 1, 2018.

Van Schooenderwoert, Nancy and Shoemaker, Brian.  Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples. Lean-Agile Partners and ShoeBar Associates, 2018

Vicente, Kim. The Human Factor: Revolutionizing the Way People Live with Technology.  Routledge, 2006.

Wilbon, Tonya A.  “An Introduction to the Quality System Regulation and Design Controls.” 2018.

European COCIR Decision Diagram for Qualification of Software as a Medical Device