Bill White started Quality System Strategies LLC in 2006, when he retired after 30 years at Bayer HealthCare LLC. At Bayer, after 20 years in R&D he worked with colleagues in the mid 1990s to establish the design control system for the diagnostics division. He then became Manager, Quality Systems Strategy, and in that role served as principal architect for the worldwide quality system of the division. Since retiring from Bayer, he has advised medical device companies ranging in size from a few persons to several thousand persons on how best to fulfill requirements of 21 CFR 820 and ISO 13485 while creating quality systems that serve the needs of the companies and their employees. Dr. White holds an A.B. in Chemistry from Harvard College and a PhD in Chemistry from Cornell University. Professional Affiliations:
American Society for Quality ASQ Midwest Biomedical Discussion Group
Association for the Advancement of Medical Instrumentation American Chemical Society Ghana Quality Organization Regulatory Affairs Professional Society
