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Edwin Bills, ASQ Fellow, RAC

Edwin Bills, ASQ Fellow, RAC
During his 27 year career in medical devices, Ed has held a number of quality and regulatory affairs positions. He is an ASQ Fellow and is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. Ed is also Regulatory Affairs Certified through the Regulatory Affairs Professionals Society and obtained BS and Masters degrees from the University of Cincinnati.

Ed served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical device participated in the development of ISO 14971 risk management standard for medical devices. Ed is a current member of the ISO Technical Committee on medical device risk management.

In 2016, he co-edited, with Stan Mastrangelo, "Lifecycle Risk Management for Healthcare Products from Research Through Disposal" published by Davis Publishing and available at www.pda.org

Ed has presented training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems, and presented courses at the University of Southern California and the University of Washington in their regulatory affairs graduate programs, and has served as an adjunct professor in the Health Products Risk Management graduate program at Virginia Tech. He has also authored several articles on medical device risk management and the chapter on risk management in "Combination Products: Regulatory Requirements and Unique Challenges", published by Davis Publishing. Currently, he is consulting in the area of medical device quality, regulatory, product liability and risk management.

Author's Posts

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums - Featured Image

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i]  As ...
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1) - Featured Image

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

The ISO Technical Committee TC 210 Joint Working Group 1 (JWG1) is a committee that reports to not o...

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