Excellence Beyond Compliance: Establishing a Medical Device Quality System

ISBN-13: 9781138491472 / Angielski / Twarda / 2018 / 216 str.

William I. White

Opis

This book looks beyond what is necessary for compliance alone to address what makes a quality management system both effective and efficient. In addition, this book never forgets that real people must make any quality management system work; the book provides a blueprint for creating a quality management systems (QMS) that will assist practitioners assure product safety and efficacy and customer satisfaction.

Spis treści

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)

O autorze

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.