EM=C²: A New Formula for Enrollment Management

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 offers readers something they can’t find in today’s most popular business books: a practical, tested perspective and strategic planning process that works for the legions of companies that don’t have the resources of an Apple, GE, or P&G. Readers will gain a deep understanding of what strategy and strategic planning is; why it’s critical to their organization and their own success; and how to create, implement and sustain a strategy that literally turns vision into reality.

Executive teams are searching for the magic elixir of success. The appeal of such alchemical magic is obvious. If a company’s managers do just this one simple thing, or follow this simple, easy plan, they too can enjoy profit margins and stock prices just like the “it” company of the moment.

The process of successfully growing an organization is like mixing chemicals together to create a reaction. Ask the typical executive to name the most valuable tool in the process of creating a chemical reaction, and they’ll offer such answers as the quantity of certain chemicals, the quality of the lab facility, the combination of two or more elements and so on. That’s because we tend to be so rooted in tactical thinking that we miss the larger equation.

The reality is that the most important tool in creating the desired chemical reaction – or growing a company – is the formula that describes its “big picture” results.

The primary formula for strategy is simple enough:

(What + Why + How) → The Future
What do we want the company to look like in the future?
Why do we want to look like that?
How do we get there?
(What + Why + How) = Strategy

This strategic planning approach derives from the author’s own alchemist-like professional search to find the magic formula for transforming the value of companies.

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