Books on Medical Device Design

The following publications can be found by means of an on-line search.

• ANSI/AAMI HE74:2001, Human Factors Design Process for Medical Devices, by Association for the Advancement of Medical Instrumentation.


• Crossing the Quality Chasm: A New Health System for the 21st Century, by Institute of Medicine.


• Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices, by David Prutchi, Michael Norris.


• Do It By Design, by U.S. Food and Drug Administration.


• FDA Inspections: A Guide for Medical Device and Diagnostic Manufacturers, by John S. Adcock.


• Good Design Practice for Medical Devices and Equipment, by Sandra Shefelbine, John Clarkson, Roy Farmer, Stephen Eason.


• Guidelines for Failure Modes and Effects Analysis (FMEA) for Medical Devices, by Dyadem Press.


• Handbook of Medical Device Design, by Richard C. Fries.


• Human Error in Medicine, by Marilyn Sue Bogner.


• IEC 60601-1 standard, Medical Electrical Equipment—Part 1: General Requirements for Safety, by International Electrotechnical Commission.


• Medical Device and Equipment Design: Usability Engineering and Ergonomics, by Michael E. Wiklund.


• Medical Error: What Do We Know? What Do We Do? (Michigan Forum on Health Policy), by Marilynn M Rosenthal (Editor), Kathleen M. Sutcliffe.


• Practical Design Control Implementation for Medical Devices, by Jose M. Justiniano, Venky Gopalaswamy.


• Six Sigma for Medical Device Design, by Jose Justiniano, Venky Gopalaswamy


• To Err Is Human: Building a Safer Health System, by Linda T. Kohn, Janet Corrigan, J. Corrigan, Molla S. Donaldson.


• Write it Right, by U.S. Food and Drug Administration.