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.
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.
Thoughts for Tuesday by: Suzanne Bates
The most successful people in the world share a common characteristic. What’s their secret? They look at the triumphs and tribulations of their lives as opportunities to learn and grow. They reflect on their personal moments to guide them along the way. And, they see the lessons in these moments as wisdom to share with others.
Each week, in her wildly popular weekly blog, “Thoughts for Tuesday,” bestselling business author and CEO coach Suzanne Bates has been doing just that – sharing everyday experiences and translating them into stories that inspire her readers. As a speaker, leadership coach, CEO, and former award-winning television news anchor, Suzanne has a unique lens through which she views life’s little moments. This anthology of Thoughts for Tuesday “fan favorites” will make you laugh, cry, and reflect. Suzanne shares compelling, inspirational, and sometimes humorous stories that will make you look back at your own personal experiences through a whole new lens.
Motivate Like a CEO: Communicate Your Strategic Vision and Inspire People to Act! by: Suzanne Bates
“An exciting read, you won’t want to put Motivate Like a CEO down until you’ve mastered all of its secrets!”
Marshall Goldsmith, New York Times bestselling author of What Got You Here Won’t Get You There
“Motivated leaders are rare, yet everyone seeks to become one. The greatness of this book is that it breaks down the process by giving you the ideas and the tools to motivate and inspire yourself first, and then others second. If you’re in a leadership position or hoping to get to the next level, make the decision to buy this book, study this book, and put it into practice.”
-Jeffrey Gitomer, author of The Little Red Book of Selling
The most successful leaders seem to possess a remarkable gift for inspiring and motivating people. They are not only hard workers who possess great business minds; they rally others to drive forward with a powerful, common vision. Motivate Like a CEO demonstrates how leaders at every level can develop this skill and use it to bring their teams together around a common purpose.
In this follow-up to her bestselling Speak Like a CEO, Suzanne Bates explains how you can become a powerful force of influence within your organization and position your company for greatness. You’ll learn how to translate simple, effective concepts into brilliant execution; get people working together on the highest priorities; and align warring factions to channel energy into the efforts that make your company profitable.
Inside, you’ll discover secrets to generate excitement all the way down the line to achieve superior results. Real-world stories of leaders who have transformed their organizations will inspire you to move your own organization to a position of strength. And, you’ll find helpful, easy-to-follow advice on how to communicate in a way that inspires people to act.
Motivate Like a CEO teaches you how to:
- Inspire people to embrace and share your vision
- Speak with energy and confidence in tough situations
- Turn challenges into opportunities
- Get your team engaged, in the loop, and tracking real results
- Make time in your schedule for sharing your message of motivation throughout your company
Even a well-positioned, strategically sound company will fail if its messages and focus are not clear. Successful leaders must be able to move the strategic plan from words on paper into the hearts and minds of the people who make it happen.
Motivate Like a CEO can help you significantly improve bottom line results, create a happier, more unified team of people, and allow you to leave a legacy of leadership.