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.
Injured Money: True Story of a Man Who Fought Insurance Companies and Won More Than a Quarter-Million Dollars, and How You Can Too! by: Dan Karr
If you buy insurance, drive a car, ride in a car, ride a bike or walk on roads where cars drive, this book is a must read. Exceptionally different than the books written by attorneys, this book is written by an injured person who recovered more than a quarter-million dollars. Based on a true story, the author takes you through the events immediately following an accident all the way to settling multiple insurance claims and a lawsuit. At every step along the way, there is a clear description of the pitfalls to avoid so that you too can maximize the money you receive.
And for those who haven’t had an accident – this book is a must read because it will give you the insight you need to choose the right auto and medical insurance companies so that you and your family members are protected when an accident occurs. Consumers have no idea what has occurred in the insurance industry over the last two decades. These changes will directly affect whether you will be compensated following an accident. After reading this book, you will be prepared to:
- Calculate the value of your injuries and determine if filing a claim is worth your time and effort.
- Take the four steps to file, negotiate and settle your claim.
- Represent yourself without an attorney to maximize financial gain.
- Hire, compensate and manage an attorney if you choose to do so.
- Know what to say to insurers, and when to say it.
- Know what not to say to insurers.
- Learn how to work with your medical insurer so they don’t cancel coverage.
- Select an auto insurance company that will honor the policy they sell you.
The final two chapters of the book analyze the insurance industry, documenting how insurance companies systematically delay and deny claims. Reading these chapters will create a shocking awareness that consumers are buying a product called insurance, but in fact are spending hard-earned money with companies that no longer honor the insurance contracts they sell. The final chapter lays out a clear plan for what consumers can do to protect them from buying insurance that won’t protect them.
Risk-Free Technology: How Small to Medium Businesses Can Stem Huge Losses From Poorly Performing IT Systems by: Charles L. Nault
IT has now reached “utility” status everywhere, at least from an expectation standpoint. Just as the utility of electricity is required to power our lights and equipment, and oil or gas insures our heat in the winter, a firm’s network infrastructure MUST be always in place to maintain its Internet access, computerization, phone system and a host of other mission-critical applications.
Contrary to days passed, companies can no longer function without these. Their customers, employees and vendors expect business networks to be fully functional, expeditious, security protected and accessible around the clock.
This book addresses the implications of failing to insure that all your IT functions are “utility-status,” and tells non-technical executives what needs to be done from a managerial perspective to achieve true utility status, as well as how to pro-actively monitor such functions to make sudden catastrophes a thing of the past. The book will provide case studies of companies who have lost money and business because they failed to heed this message.
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.
Fresh Ink by: Chloe Lizotte
In 2007, Chloe Lizotte, then a student in middle school, wrote an “Historical Thoughtleader Profile” on Elizabeth Cady Stanton, the women’s suffrage leader, which she then published on a website. A few isableays later, she received a request from a professional women’s website called Women in Technology International (WITI) which wanted to re-publish it. That was the beginning of Chloe’s journey into professional publishing which, over the ensuring years, included a series of columns on still more historical “thoughtleaders” for The Concord Journal as well as music and arts reviews in her high school newspaper The Voice (which she also served as editor-in-chief) and various op-ed pieces, reviews, news reports and reflective essays in prominent journals like Teen Ink, The Real Musician, Booklore, The Pulitzer Center, CEO Refresher and Op-Ed News. The next step logically implied a book, resulting in “Fresh Ink: Published Writings,” a compilation of all her published content. Each chapter in “Fresh Ink” is a previously published work specifically selected for publication by an editor. No chapter content in “Fresh Ink” has been included that does not meet that requirement. “The essays in my book reflect where I’ve been, what I’ve seen, how I’ve reacted and what I’ve concluded,” Chloe explains. “They speak to my journey up to this stage in my life.” Chapter topics in the book range from music reviews (“The Suburbs” and “The King of Limbs”) to literary legends (Hemingway, J.D. Salinger) to political history (The 1920s youth culture, Martin Luther King) to Steve Carell’s leaving “The Office” to profiles of historical eccentrics, movie reviews, a report on the 2011 summer London riots and a self-reflection titled “The Thoreau Challenge.” A comment online of the website that published Chloe’s essay on Martin Luther King remarked: “(Chloe is) an amazingly cogent thinker, proving that age has nothing to do with intellect, discernment, wisdom, and that all-important passion for one’s subject matter — and for truth.” Another commenter confided: “I was about to give up on our youth but your wonderful writing has renewed my faith.” Now a member of Yale’s class of 2016, Chloe graduated from Concord-Carlisle High School in 2012 after serving as editor-in-chief of its student newspaper The Voice and music director of its radio station WIQH-FM. In addition to her column about “historical eccentrics” in the town of Concord’s weekly newspaper The Concord Journal, she also won the 2011 University of Virginia Book Award. Her twice-monthly radio show on WIQH achieved the station’s “Outstanding Show of the Year” award three years running. She is also an accomplished piano and guitar player, an avid snowboarder, kayaker and runner, and a talented videographer. Chloe’s reporting on the London riots for the renowned Pulitzer Center happened largely due to her love of all things British, including four trips to London and a summer study program at Cambridge College (2011). She has also visited Ireland, Scotland, Wales, Montreal and Paris. She lives with her family in Concord, Massachusetts.