System Safety Bookshelf: Applying Safety Standards to Life-Saving Equipment

Clif Ericson

doi:10.56094/jss.v55i1.53

Authors

C.A. Ericson

DOI:

https://doi.org/10.56094/jss.v55i1.53

Keywords:

medical, safety critical, risk management, ISO 14971, BXM

Abstract

Elsevier Academic Press has recently published a new safety book titled Safety Risk Management for Medical Devices, written by Bijan Elahi. This book explains how to conduct a risk management program that will show conformance to the FDA safety standards established for medical devices. It describes a safety process as well as some of the tools utilized in the process. Since medical devices are life-saving devices, they can be deemed as “safety critical,” requiring a rigorous process to ensure they are safe for public use.

Author Biography

C.A. Ericson

Clifton Ericson II has 45 years of experience in the field of system safety, software safety, reliability, and fault tree analysis. He currently works for URS Corporation (formerly EG&G) where he provides technical analysis, consulting, oversight and training on system/software safety projects. He currently supports NAVAIR systems safety on the UCAS and BAMS unmanned aircraft systems, and he is assisting in writing NAVAIR system safety policies and procedures. Mr. Ericson was employed as a Senior Principal Engineer for the Boeing Company for 35 years. At Boeing, he worked in the fields of system safety, reliability, software engineering and computer programming. Mr. Ericson has been involved in all aspects of system safety, including hazard analysis, Fault Tree Analysis (FTA), software safety, safety certification, safety documentation, safety research, new business proposals and safety training. He has worked on a diversity of projects, such as missile systems, people mover systems, commercial aircraft, B-1A/B-2 bombers, AWACS, EPRI solar power system, and the Apollo Technical Integration program.

He served as President and Vice-President of the System Safety Society and was Co-Chairman of the 16th International System Safety Conference. He is the founder of the Puget Sound chapter (Seattle) of the System Safety Society. In 2000, he won the Boeing Apollo Award for safety consulting work on the International Space Station, and the Boeing Achievement Award for developing the Boeing fault tree analysis course. Mr. Ericson won the System Safety Society’s President’s Achievement Award in 1998, 1999 and 2004 for outstanding work in the system safety field.

He is author of the books, “Hazard Analysis Techniques for System Safety” (2005) and “The Concise Encyclopedia of System Safety Terms and Definitions” (to be released in April 2011). He has published many technical articles in system and software safety and is currently editor of the Journal of System Safety (JSS), a publication of the System Safety Society. Mr. Ericson has taught courses on software safety and fault tree analysis at the University of Washington and in Singapore and Australia. (from clifericson.com)