1st Edition

Excellence Beyond Compliance
Establishing a Medical Device Quality System




ISBN 9781138491472
Published May 24, 2018 by Productivity Press
216 Pages - 30 B/W Illustrations

USD $51.95

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Book Description

Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.

This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.

After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.

This book offers:

  • Advice that will lead to an effective and efficient QMS.
  • Detailed guidance on the key decisions to be made regarding the quality system being established.
  • Detailed ideas on how to execute those decisions.
  • Up-to-date information on compliance to current regulations and standards and guidance on staying up to date.
  • Specific examples of procedures.
  • Information regarding requirements for combination products, such as a drug + device combination.
  • Advice on incorporating risk management in the QMS.

Table of Contents

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)

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Author(s)

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.