PDF Download Medical Device Development: Regulation and LawBy Jonathan S. Kahan

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Medical Device Development: Regulation and LawBy Jonathan S. Kahan

PDF Download Medical Device Development: Regulation and LawBy Jonathan S. Kahan

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Medical Device Development: Regulation and Law, 2nd 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. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of 2002, including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of Combination Products. * The Food and Drug Administration Amendments Act of 2007, including unique device identifiers, ClinicalTrials.gov registration, pediatric device promotion, and postmarket surveillance and medical device reporting changes. * The current and future landscape of electronic 510(k) and PMA submissions. New chapters and features in the second edition include: * Medical Device Compliance and Postmarket Surveillance requirements. * Quality System Regulation, including management controls, design controls, risk analysis and corrective and preventive action, and other QSR provisions. * In Vitro Diagnostics, including IVD clinical studies, ASR regulation, LDTs, CLIA, and IUO/RUO requirements. * Combination Products and Product Jurisdiction, including a description of FDA s jurisdictional decision-making for single entity products, the establishment of the Office of Combination Products and its jurisdiction and processes, with a detailed discussion of the new definition of the primary mode of action. * A glossary and comprehensive index of terms and concepts.

• Sales Rank: #1098330 in Books
• Published on: 2009-08-17
• Original language: English
• Number of items: 1
• Dimensions: 9.50" h x 6.50" w x 1.50" l, 2.54 pounds
• Binding: Hardcover
• 550 pages

About the Author
Jonathan S. Kahan, Partner, Hogan & Hartson LLP in Washington, D.C., is a co-director of the firm's food, drug, medical device, and agriculture group. Jonathan has been practicing in FDA law for 35 years. 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. Jonathan has published numerous law review and other articles concerning FDA regulatory issues.

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Free Download UNIX Systems Programming: Communication, Concurrency and Threads by Kay A. Robbins (June 27,2003)

Free Download UNIX Systems Programming: Communication, Concurrency and Threads by Kay A. Robbins (June 27,2003)

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UNIX Systems Programming: Communication, Concurrency and Threads by Kay A. Robbins (June 27,2003)

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Product details

Hardcover

Publisher: Prentice Hall (June 27,2003) (1602)

ASIN: B015X3ZAI0

Average Customer Review:

4.2 out of 5 stars

20 customer reviews

Amazon Best Sellers Rank:

#3,316,004 in Books (See Top 100 in Books)

I used this book to start to learn from scratch how to programming Unix. This book is self-contained,concise and easy to read. FYI, it is very readable and not dry. There's a number of good diagrams, for example,illustrating file descriptors allocations and the effects of system calls like dup2, etc. The authors uses short code snipplet to illustrate how to use a particular system calls, which I think is rather neat. A number of "projects" very quickly help reader to expand their skill level. Of interest is also a project on distributed "Richard" and "Linda" , the forerunner of Sun's JINI. The authors could have expanded this book another 100 pages and make it a companion to Steven's "Advanced Unix System Programming". I strongly recommend this book to beginners, intermediate Unix Programmers.

This is an awesome book. You'll have to be patient when going through it. And you'll learn a lot if you follow along with the examples and make everything work. It took me probably 6 hours just to get through chapter 2 - not because I can't read, but because I'm paying attention to every little detail, and making sure I learn what's going on.The other thing that came as a big surprise, was that this is the best introduction to C i've come across. I've read quite a few books on C. Generally, I get through these other books on C - I get the syntax and pointers, and headers, etc. What I can never get through in these other C books, is that they use Math for all the examples. Which bores me, and sometimes frustrates me - because what I want to do with systems programming is not math - that's just me.Of all the C books I've read, this one, and "C - A Reference Manual 5th Edition" are the best C books.One pitfall in the book, is that with most of the examples, the conditionals to check pointers, and some other conditionals are somewhat amateur looking (that's just me). For example, in chapter 2, the "listlib.c" file has tons of conditionals like this:list_t **newptrs;if(headptr == NULL){ errno = EINVAL; return -1;}That started to confuse me, why not just write:list_t **newptrs;if(!headptr){ errno = EINVAL; return -1;}Which is ok. So there are many times where it seems the author is either purposefully writing conditionals to be verbose for readers, or doesn't know how to simplify with "not" flips.Another example:if(ptr != NULL)can be simplified to:if(ptr)Other than those small things, this book is great.EDIT: One other thing that's slightly annoying.The authors like to put all of their code in conditionals. Like this:if ((sigemptyset(&twosigs) == -1) || (sigaddset(&twosigs, SIGINT) == -1) || (sigaddset(&twosigs, SIGQUIT) == -1)) perror("Failed to set up signal mask");For me that's ok in only a few places. They do it everywhere and it's really annoying. Maybe they did it just to save space in the book?

its a texbook

Fantastic book with great code examples and exercises. The discussion and examples escalate very quickly so much prior knowledge is recommended. I would recommend it to anyone that is wanting to learn about UNIX.

This is an invaluable reference to keep close at hand if you are a programmer supporting UNIX. The only thing I didn't find in this text is how to change your process name on-the-fly. Everything else I've looked for was there, and in most cases, described in detail.If you do systems programming on UNIX then you should have this book.

Lots of useful sample programs

If Stevens is the Old Testament this book is the New Testament.I was thinking lately what it is about Stevens books that has made them the best material in the industry for the past decade. I cant really nail it, if I could I would have been an author myself and make millions, but the other day it suddenly hit me: When I read Stevens books sometimes a question arises and then I pause to think about it, only to turn the page and find the answer witinf for me. It is about being comprehensive, it is about covering all aspects of the topic, thinking forward on behalf of the reader, thinking what the reader may not understand and how to make it clear.Well Robbins and Robbins belongs to this category of books.I am a book maniac and I have most of the Unix/Linux programming books out there. This is by far the best systems programming book available.The other day I had to look up about asynchronous i/o in Linux and its interaction with POSIX real time signals. Opened the book, read the example, downladed the source code, in an hour I was flying and writing an asynchronous web server in Linux.For the networking stuff I never bothered to read the relevant chapters of the book since Stevens Network programming is the book I was trained by and it is still relevant.For my threading needs I used to use Butenhof's "Programming with POSIX threads", but this book has great examples and I learned a lot by browsing it. I mean I had a question about signal interaction with threads and the book had a section about it. Come on, it has saved my butt many many times. It is very comprehensive.I wholeheartedly recomend it to any serious systems programer, beginner or advanced.

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Free Ebook Essentials of Anaesthetic EquipmentBy Baha Al-Shaikh, Simon G. Stacey

Free Ebook Essentials of Anaesthetic EquipmentBy Baha Al-Shaikh, Simon G. Stacey

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Essentials of Anaesthetic EquipmentBy Baha Al-Shaikh, Simon G. Stacey

Free Ebook Essentials of Anaesthetic EquipmentBy Baha Al-Shaikh, Simon G. Stacey

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Prepared by authors based in the UK, this highly practical, illustrated guide continues to provide an up-to-date introduction to anaesthetic equipment and its use in clinical practice. An invaluable resource for all those who work with anaesthetic equipment, including anaesthetists studying for the FRCA examinations, nurses and operating department practitioners, this new edition has been completely updated to reflect current equipment and training requirements. Lavishly illustrated throughout with colour photos and clearly-drawn line illustrations, Essentials of Anaesthetic Equipment, third edition, retains the superbly organized and easy-to-read format that has made the previous two editions such a success.

• The same portable size is retained for the new edition
• An ideal book for the busy trainee or practitioner to carry around the hospital and 'dip into' when the opportunity presents
• A selection of MCQs is included at the end of each chapter providing an opportunity for the reader to test their knowledge - an ideal aid to exam preparation
• Highly illustrated with colour photographs and diagrams throughout to aid recognition in the clinical environment and demonstrates essential points
• Standardised format used for each piece of equipment: components, mechanism of action, problems in practice and safety features
• Summary boxes in every chapter highlighting key points and safety considerations help the reader remember key information and breaks down the text into manageable chunks. Especially helpful when preparing for exams
• Equipment checklists include essential information that all users of anaesthetic equipment need to know

• The content for the new edition reflects more closely the current FRCA syllabus
• New section on latex allergy
• Illustrations of now-obsolete equipment replaced with the latest models in use
• Discussion of bispectral monitoring now included
• Chapter on electrical safety expanded
• Chapter on sterilisation and cleaning added
• Rapid infusion devices discussed

• Sales Rank: #883852 in eBooks
• Published on: 2013-03-05
• Released on: 2013-03-05
• Format: Kindle eBook

Review

Reviews of the previous edition:

British  Journal of Anaesthesia:

• a valuable source of information for those interested in learning about anaesthetic equipment and how the various types of product operate
• easy to read, clearly laid out, and well illustrated.

Anaesthesia 

• the book covers just about everything you need to know about anaesthetic equipment and there is certainly a need for a book such as this
• attractive, well written and well laid out, and not hugely expensive
• I would recommend it as an excellent starting manual for novice anaesthetists, as well as for trainees preparing for their FRCA examinations

European Journal of Anaesthesiology

• well written with excellent illustrations and high production values
• design is most suitable for those preparing for examinations and for trainers alike
• authors offer a consistent style that minimizes repetition, while highlighting key points
• keeps pace with medical innovation in anaesthesiology and should prove a popular text

Acta Anæsthesiologica Belgica

• a welcome addition to find its way into the broad and often confusing armamentarium of modern anesthesiologists.
• warmly welcomed by trainees and teachers alike as it is easy to read, very well illustrated and as a clear and accurate guide to successful techniques.

BMA Book Awards - Highly Commended

• it’s easy-to-read with clear diagrams and pictures that reinforce the text to great effect

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