What Would Henry Do?: Essays for the 21st Century

Here s the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.

Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation — to build confidence in your software s safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.

From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer s quality system and is regulated by 21 CFR 820.70(i).

DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book.

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This book reveals a new concept that all great leaders have utilized but few if any have recognized: By presenting followers with a goal that offers a better future, thereby eliminating fears or major concerns, the leader creates an environment where teamwork naturally thrives, making extremely difficult objectives obtainable. This motivates followers, eliminating the need to utilize critical resources for motivation, and creating an efficiency that no supervision could ever achieve. Once followers start working as a team for the good of the organization, improvements naturally follow, especially in quality. Until now, definitions for quality have been vague and unhelpful at guiding organizations on where to improve. The new definition for quality introduced in this book will assist leaders in any organization to clarify exactly what quality is for that organization, making it possible for each worker to improve their products and services with each action taken. The benefits gained will improve employee and customer satisfaction to previously unheard-of levels. A clarification of how feelings impact overall results will change how future employees and organizations behave, creating an environment that is highly sustainable. Chris Whipple, president of Advanced Corporate Teams, provides training to develop Advanced Corporate Executives (A.C.E.). With over 20 years of management experience and a desire to share best practices, he set out to document a clear process for implementing goals. His research uncovered several missing details that the quality gurus never discovered. This book fills in the gap. He is a graduate of Johnson & Wales University in business management and can be contacted via the Advanced Corporate Teams website: www.advancedcorporateteams.com.

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