This tutorial introduces the general processes for the design and development of bio-medical instrumentation. It will include process stages such as standards, regulations, certification, development phases, documentation, plans, procedures, and reviews. The tutorial will also address concerns over configuration control, archiving, and traceability and how to meet and deal with the government bodies on food quality control such as the U.S. Food and Drug Administration. Finally, the tutorial will include a case study from the presenter's own experience with medical device development.

Kim Fowler has spent 29 years developing medical, military, and satellite equipment. He co‐founded a medical products company and worked in the aerospace industry. Kim consults on engineering processes in designing and developing products and systems. He is the President of the IEEE Instrumentation & Measurement Society for 2011.

Further information regarding this event is available at http://www.iium.edu.my/iccce/12/index.php/kim-fowler-tutorial

Brochure for this event is available at http://www.iium.edu.my/iccce/12/images/keynote/KimFowlerTutorial.pdf