Preventing Medical Device Recalls

"Based on the author's extensive experience in the medical devices and manufacturing engineering industries, this book can save medical device companies millions of dollars by preventing many deaths and costly recalls. It is the first to show how to control safety risks, starting from specifications to safely retiring the products without harm to the environment. The book covers medical device requirements, preventing recalls during specification writing, risk assessment and management, preventing recalls during design and development, and much more"--Provided by publisher.

Dev Raheja, MS, CSP, has been an international risk management and quality assurance consultant in the healthcare, medical device, and aerospace industries for more than twenty-five years. He applies evidence-based safety techniques from a variety of industries to healthcare.

He is a trainer, and author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to create elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, the United Kingdom, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major company in the Midwestern United States avoid going out of business and become a world leader by eliminating safety mishaps.

Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance and manager of manufacturing, and at Booz-Allen & Hamilton as a risk management consultant for the nuclear and mass transportation industry.

Raheja served as adjunct professor at the University of Maryland for five years in its PhD program in reliability engineering, and is currently an adjunct professor at Florida Tech for its BBA degree in healthcare management. He is associate editor for healthcare safety for the Journal of System Safety, and teaches webinars on medical device safety and reliability.

He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from the System Safety Society and the Austin Bonis Reliability Education Award from the American Society for Quality.

He served as part of the first group of examiners for the Malcolm Baldrige National Quality Award, and served for fifteen years on the board of directors of the Annual Reliability and Maintainability Conference sponsored by ten engineering societies. Currently he is the member of the Institute of Electrical and Electronics Engineers (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), the American Society of Patient Safety Professionals, and the American College of Healthcare Executives.

Raheja majored in human factors engineering as a part of his master’s degree in industrial engineering, is a Certified Safety Professional through the Board of Certified Safety Professionals, and serves as the chairman of the Design for Reliability Committee of the IEEE.