1st Edition
Excellence Beyond Compliance Establishing a Medical Device Quality System
Chapter 1 The Challenge
Chapter 2 The Path
Chapter 3 Key Decisions
Chapter 4 A Quality Plan
Chapter 5 Documentation, the Big Picture
Chapter 6 Level 1 Documentation
Chapter 7 Level 2 Documentation
Chapter 8 Level 3 Documentation
Chapter 9 Level 4 Documentation
Chapter 10 Fully Incorporating Risk Management
Chapter 11 Implementation
Chapter 12 Maintenance (and Improvement)
Biography
Bill White started Quality System Strategies LLC in 2006 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.
