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Medical Device Development: Regulation and Law, 2014 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. Since the 2009 edition of this book, new device legislation has been enacted and FDA has issued over a dozen or more important new guidances. The 2014 edition features in-depth analysis of these developments, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the US. The 2014 edition of this popular and authoritative resource reviews and analyzes the following critical developments since the 2009 edition: * Update on all the new provisions of the Food and Drug Administration Safety and Improvement Act of 2012 (FDASIA). * New statutory provisions and guidances related to device reclassification, humanitarian devices, the CDRH appeal process, Section 522 postmarket surveillance, and custom devices. * New statutory provisions and guidances related to mobile medical apps and medical device software, including medical data software systems. * Updates on the new organizational structure of CDRH, including revisions to the structure of the Office of Device Evaluation the Office of Compliance, and the Office of In Vitro Diagnostics and Radiological Health. * Changes to the 510(k) premarket notification process, including new policies on split predicates, when a device cannot be found to be SE, and the new priority review guidance. * Changes to the pre-submission process, including the end of the pre-IDE process and the birth of the Q-sub. * New guidances on FDA s Refusal to Accept policies relating to 510(k)s, PMA s, and pre-submissions. * Update on the investigational device exemption process, including new guidances on early feasibility studies, FDA decisions for IDE investigations, design considerations for pivotal clinical device investigations, and good laboratory practices. * Changes to the premarket approval application process, including birth of the e-copy and modifications to the advisory panel process. * New policies and guidances concerning in vitro diagnostic products, including the new guidances on Research Use Only (RUO)/Investigational Use Only (IUO) products, and in vitro companion diagnostics. * Update on device compliance issues, including the 2013 draft medical device reporting guidance and recall procedures relating to product enhancements. * New guidances and cases relating to combination products incorporating medical devices.

• Sales Rank: #61011 in Books
• Published on: 2014-03-01
• Binding: Hardcover
• 622 pages

Review
Great book for a beginner learning about process, or an experienced practitioner in the field. I used prior addition, until i realized it was updated - i testify on matters of value in the field of medical devices, and nothing helps the court understand faster - than a text book you can cite documenting the process of a 510(k) application or a PMA! --Richard Mackenzie, Amazon Verified Purchase

I recently acquired a copy of Jonathan Kahan s book entitled Medical Device Development: Regulation and Law, in its most recent edition. I have been in the regulatory affairs profession for over 23 years now, and can easily navigate websites and references to find the information I need. However, as I was reviewing a recent FDA proposed rule, I found myself repeatedly reaching out to the book as all the information I needed was compiled and easily found in one place, organized by topic, with all needed legislative and regulatory references. Mr. Kahan has done an admirable job in creating this book, and I am thankful to have it on my desk for easy reference when needed. --Tamima Itani, Ph.D., FRAPS, RAC MSVP, Global Regulatory Affairs and Regulatory Compliance, Boston Scientific

About the Author
The book is written by Jonathan S. Kahan, Partner, Hogan Lovells US LLP in Washington, D.C. Jon is a co-director of the firm s food, drug, medical device, and agriculture group, and has been practicing in FDA law for 40 years. Jon is also an Adjunct Professor at the George Washington University Law School teaching medical device law. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jon has published numerous law review and other articles concerning FDA regulatory issues.

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• Sales Rank: #1478220 in Books
• Published on: 2014-07-14
• Original language: English
• Number of items: 1
• Dimensions: 8.50" h x .10" w x 5.50" l, .13 pounds
• Binding: Paperback
• 42 pages

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Review

“Doug Stephens sounds the alarm for brick-and-mortar retailers (and their landlords), and those who do not heed his advice do so at their own peril. Reengineering Retail is a survival guide for those of us navigating a sea change in physical retail.”―Mark Toro, Founder and Managing Partner, North American Properties–Atlanta, Ltd.“Ten years ago, walking into a cool boutique to see a DJ spinning was novel. Today, it’s about the least a store can do to keep up with the times. Brands and retailers that are standing out are pulling out the stops to turn shopping into a rich and immersive experience that leverages technology. Doug’s book sets out a roadmap for how to best compete in this new retail world” ―Harley Finkelstein, COO, Shopify“Disruption is facing every business. Retail is feeling the brunt of it. Technology changes everything. Software eats retail in a one-click and swipe-right world. Retailers talk about omnichannel and customer-centricity, but look at the landscape. It's hard to be optimistic. Still, big thinkers like Doug Stephens and his latest book, Reengineering Retail, draw the map and demonstrate what retailers need to think and do in this landscape. If you sell stuff, this is a must-read.” ―Mitch Joel, President, Mirum. Author of Six Pixels of Separation and CTRL ALT Delete.“Retail is no longer linear―it doesn’t live in a protected tower―and it’s arguably facing its greatest disruption ever! Doug Stephens’ latest book, Reengineering Retail, shines the spotlight on the new ecosystem, one that feeds off innovation, the redefinition and refinement of customer experience, authenticity, value, excitement and experimentation. Doug’s book challenges us to look at disruption more than by assuming that one form of retail will win over another―simply put, the book forces us to understand the power of personalization and customer engagement―the lifeblood of our new retail world.” ―Diane J. Brisebois, President & CEO, Retail Council of Canada“Doug Stephens paints a vivid picture of the massive disruption and reinvention that is occurring in the retail landscape. Reengineering Retail offers valuable insights into how the physical and the digital retailing worlds will augment each other and combine to create customer experiences that we can only imagine today. This book is a must-read and a wakeup call to any retailers that have been technological laggards.” ―Ramesh Venkat, Ph.D., Director, David Sobey Centre for Innovation in Retailing, Saint Mary’s University

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From the Inside Flap

In his first book, The Retail Revival, author and internationally renowned consumer futurist Doug Stephens correctly predicted the end of an era in retailing and the dizzying growth of online giants like Amazon and Alibaba.com. Change in the global retail sector continues to accelerate at an exponential pace, surpassing even the boldest forecasts. In fact, retail is being entirely reengineered―every aspect of the retail experience as we know it will soon be radically transformed. Picking up where Retail Revival left off, Reengineering Retail explores the coming retail revolution, which will affect retailers of all sizes―and any business with a stake in the global retail industry. Stephens paints a bold vision of the future, where the very concept of what a store is, how consumers shop and even what retail’s core revenue model is will all be profoundly reinvented, and he illustrates the vast opportunities available for courageous brands and business leaders with the foresight to begin adapting to the new realities now. Hundreds of well-known brick and mortar retailers have already closed their doors, and brands and retailers across categories are struggling to understand consumers’ shifting needs and expectations. Infused with real world examples and insights from industry disruptors, Reengineering Retail offers retail executives an essential roadmap to the future.

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Product details

Hardcover: 256 pages

Publisher: Figure 1 Publishing (April 11, 2017)

Language: English

ISBN-10: 1927958814

ISBN-13: 978-1927958810

Product Dimensions:

6.3 x 1.1 x 9.1 inches

Shipping Weight: 1 pounds (View shipping rates and policies)

Average Customer Review:

4.9 out of 5 stars

34 customer reviews

Amazon Best Sellers Rank:

#164,750 in Books (See Top 100 in Books)

Doug Stephens follows up his seminal work, The Retail Revival, with a brilliantly researched and well-articulated view on the vastly changing retail landscape. Rather than hypothesize about what retail might look like in five or ten years, Stephens draws on current examples to inform his perspective. He points to the ever-growing nature of AI to redefine the retail experience and lays out a case as to how retail is being influenced by forces not traditionally of the sector. For instance, he shows how Amazon's obsession with new technology and innovation is and will continue to influence bricks and mortar developments by both putting many retailers out of business, even as it drives others to greater levels of innovation and relevance. If you are serious about retail this is a must-read. Peter Smith, Author, Hiring Squirrels and Sell Something

Mildly terrifying and completely exhilarating, this is a must read for anyone contemplating the future of retail or looking to make radical improvements in their business right now. Tools, tactics, and strategies abound in this hard to put down book. Whether you own brick and mortar stores or an ecommerce site, Re Engineering Retail offers valuable insight, deeper understanding of customer behavior and motivation, and digital trends. Well worth the time.

As a person who has spent well over thirty years in retail technology I have seen and experienced all of what Doug lays out in this book. I do agree that the time has come for a changing of the guard in retail.It is a wonderful time if you can reflect and be an active participant and not a deer in the headlights.

If you are a retailer big/small/brick & mortar/online you need to read this book. The future is certainly unknown but this book will get you thinking in the right direction.

A field guide into the retail revolution that effects us all. And, an educated look into the future of the retail experience. Jaunty writing and solid research. I’ll be recommending often

Doug is an old school retailer helping you steer through new retail, ecommerce, DTC, Amazon and the emerging state of play.

Doug Stephens is incredibly insightful, with a great vision. I was inspired and motivated to think about retail in a different manner!

Doug is by far my favorite futurist author. What I love the most is the back and forth from how we got to "x" point to where we are going in the future. We can see things in his book being implemented into the market almost in real time.

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• Sales Rank: #1063443 in eBooks
• Published on: 2016-01-20
• Released on: 2016-01-20
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Free Ebook The Snag of The Sword: An Exegetical Study of Luke 22:35-38 (New Testament Studies in Contextual Exegesis. Neutestamentliche Studien zur ko

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The Snag of The Sword: An Exegetical Study of Luke 22:35-38 (New Testament Studies in Contextual Exegesis. Neutestamentliche Studien zur ko

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Lk 22:35-38 is peculiar because it is never proclaimed except on Palm Sunday in the Year C. Although it is a pragmatic instruction on mission, it puzzles us like the Apostles in the Upper Room. The Lord shortly before his arrest, asserting the importance of the teaching, mandates preparedness for mission in the post-resurrectional period of the Church. The shepherd must be prepared to defend the sheep under his/her care, even to the extent of being called «lawless» according to world standards. Lk 22:35-38 thus in no way contradicts the prior mission training sendings, rather endows the missionary with greater strategic responsibility and commitment in pastoral care. The book highlights the contextual, hermeneutical, and theological dimensions in the final teaching of Jesus in the Lukan narration.

• Sales Rank: #5184420 in Books
• Published on: 2014-07-29
• Original language: English
• Number of items: 1
• Dimensions: 8.25" h x 6.00" w x 1.00" l, .0 pounds
• Binding: Hardcover
• 244 pages

About the Author
Thomas Kattathara S.J. entered the Society of Jesus in the Dumka-Raiganj Province after completing his university studies. Involvements in the social, pastoral and formation apostolate of the Society have greatly influenced his exegetical research. He is now teaching Scripture in the Jnana-Deepa Vidyapeeth, Pune (India).

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The Snag of The Sword: An Exegetical Study of Luke 22:35-38 (New Testament Studies in Contextual Exegesis. Neutestamentliche Studien zur ko PDF

The Snag of The Sword: An Exegetical Study of Luke 22:35-38 (New Testament Studies in Contextual Exegesis. Neutestamentliche Studien zur ko PDF

The Snag of The Sword: An Exegetical Study of Luke 22:35-38 (New Testament Studies in Contextual Exegesis. Neutestamentliche Studien zur ko PDF

Free PDF Business ChineseBy Jiaying Howard, Tsengtseng Chang

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Business ChineseBy Jiaying Howard, Tsengtseng Chang

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• Sales Rank: #465816 in Books
• Brand: Brand: The Chinese University Press
• Published on: 2005-06-29
• Original language: English
• Number of items: 1
• Dimensions: .69" h x 7.28" w x 10.30" l, 1.56 pounds
• Binding: Paperback
• 311 pages

• Used Book in Good Condition

About the Author

Jiaying Howard is head of the Chinese program at the Graduate School of Languages and Educational Linguistics of the Monterey Institute of International Studies, California.

Tsengtseng Chang is a curriculum and material development specialist at the Defense Language Institute, Monterey, California.

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