Medical Device Software Verification, Validation and Compliance by: David A. Vogel
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.
Shut Up and Say Something: Business Communication Strategies to Overcome Challenges and Influence Listeners by: Karen Friedman
For business people looking to get results and up their income, this book divulges no-nonsense strategies that can turn anyone into a powerful speaker who can overcome challenges and influence the right listeners.
• Provides hands-on, easy-to-use tools to help anyone improve their business communication skills
• Contains original heartwarming stories, examples, and lessons learned from the author’s 20-year career in television news, a run for political office, and advising some of the nation’s biggest companies
• Every chapter contains topical session examples, stories, “Coaching Notes,” “Quick Fixes,” and subject-related quotes
• The index helps readers easily locate specific topics and references to key terms
The Emerging Markets Handbook: An analysis of the investment potential in 18 key emerging market economies by: Pran Tiku
FINDING TOMORROW’S MARKETS FIRST Tomorrow’s booming economies are today’s emerging markets. Overlooked by most investors, these markets offer serious opportunities for those prepared to move ahead of the crowd and take their investing off the beaten path. If you’re an investor unafraid of the unfamiliar and looking to carve out extraordinary opportunities in new markets, this book should be your starting point. THE EMERGING MARKETS HANDBOOK provides investors with a highly detailed examination of 18 countries that could host the stock market stars of the future – from Chile and China to Thailand and Turkey. At its heart is an analysis of the 18 economies’ strength and potential for growth. This assessment is based on the ten crucial drivers of growth, including demographics, business conditions, capital markets and more. Following exhaustive research into the numbers behind each of these drivers, Pran Tiku is able to draw on a wealth of data from respected sources to form conclusions about the current position and future prospects of each market. He illustrates this data with explanatory charts and tables, allowing readers to trace recent trends and compare this to where the countries stand now. Providing a groundbreaking ranking of all emerging markets, the author goes on to sort them into standouts, in-betweeners and strugglers. This means you can truly see which markets offer the most commanding opportunities, which have room for development and which currently present a poorer investment case. Finally, the HANDBOOK concludes with a look at investment vehicles that can be used to access emerging market investments and a survey of the industries and companies that are likely to be the primary players within these 18 economies in the future. THE EMERGING MARKETS HANDBOOK is your indispensable guide to finding the future’s hottest markets. No investor can afford to be left behind.
The Chemistry of Strategy: Strategic Planning for the Not-Yet-Fortune 500 by: John W. Myrna
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.