Review

Finally, a real manual that for the first time supports efficient medical device development-Peter H. Muller, President, Interform Product DevelopmentThe Keiretsu Forum is America’s largest angel investment group. We see hundreds of presentations for innovative start up companies. This is a resource that will help medical device innovators develop better products, and more focused companies, more quickly-Randy Williams, Founder The Keiretsu ForumThe Keiretsu Forum is Americas largest angel investment group. We see hundreds of presentations for innovative start up companies. This is a resource that will help medical device innovators develop better products, and more focused companies, more quickly-Randy Williams, Founder The Keiretsu ForumThis is the first in its class of multidisciplinary books for medical device innovators, reaching across several disciplines to capture what innovators need-Michael Gertner, MD, Co-Director, Surgical Innovation Program at Stanfo (more…)

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques.Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related – directly and indirectly – to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

(more…)

Review

“Beautifully presented.. This textbook contains a very comprehensive and well-illustrated review of the role of Doppler sonography in obstetrics and gynecology.”–ASUM Ultrasound Bulletin

This beautifully illustrated and formatted book covers all of the established and developing indications for the use of color Doppler ultrasound in gynecology and obstetrics.  In gynecology the modality is used to measure blood flow in benign changes of the endometrium as well as malignant tumors of the uterus; screening for ovarian carcinoma, including 3D-power doppler for the assessment of angiogenesis of ovarian tumors; and as an adjunct examination in assessing tumors of the breast. In obstetrics, the imaging method is useful in screening for gestosis and placental insufficiency in early pregnancy; evaluating the umbilical cord; fetal echocardiography and much. More recent developments s (more…)

Book Description

Univ. of California, San Diego. Textbook presents completely expanded and reorganized coverage. Vol. one covers general ultrasound applications, and volume covers obstetrics and gynecology. Each chapter begins with a list of key terms and definitions and ends with review questions. Previous edition: c1995. For students. Abundantly illustrated. DNLM: Ultrasonography.

(more…)

Review

From the reviews of the second edition: “This is a thorough resource on ultrasound imaging of peripheral nerve disease. … It is written for practicing radiologists, neurologists, plastic surgeons, and orthopedic surgeons who are involved in the diagnosis of peripheral nerve disease using ultrasound. … a useful addition to the library of any physician involved in ultrasound imaging of peripheral nerves. This second edition is updated with improved ultrasound images and discussion of recent advances in the literature.” (Julie Sossaman, Doody’s Review Service, August, 2008) “The authors, contributors, and editors have compiled their extensive personal experience, original research … in the fields of anatomy, neurology, and surgery into a textbook that is well written, nicely illustrated, and effortlessly understandable. … this latest addition to the Medical Radiology/Diagnostic Imaging series is indispensable to those interested in using sonography to (more…)

An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author’s and other researchers’ previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the devel (more…)

Review

Using an engineering approach, the fundamentals of electronic medical devices are presented along with the basic medical knowledge deemed necessary for design considerations. After addressing power subsystems, chapters address a range of sensors. The processes of data acquisition and digital signal processing are also considered. The material is accompanied by examples of technologies and numerous schematic diagrams.Book News, Inc.r, Portland, OR — Review

Review

Using an engineering approach, the fundamentals of electronic medical devices are presented along with the basic medical knowledge deemed necessary for design considerations. After addressing power subsystems, chapters address a range of sensors. The processes of data acquisition and digital signal processing are also considered. The material is accompanied by examples of technologies and numerous schematic diagrams.Book News, Inc.®, Portland, OR

See all Editorial Rev (more…)

Review

“This book is an absolute must for anybody who is just overwhelmed by the prospect of having to go through the various standards that are becoming increasingly important to manufacturers and users alike. . ..It not only explains every aspect of the science of reliable design but provides clear definitions of the jargon and good practical examples of the paperwork required from the various certifying bodies. . . .it is unlikely that most of us will ever need to refer to any other book than this one. ” —Proceedings of the Institution of Mechanical Engineers
–This text refers to an out of print or unavailable edition of this title.

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its (more…)

This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents. This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable (more…)

This text offers the student a firm grounding in normal anatomy and physiology from an ultrasound perspective. After covering anatomy and physiology in the first half of each chapter, it then presents a wealth of ultrasound images to increase the reader’s comfort with normal anatomy as it appears during scanning. Most images are accompanied by labeled drawings with detailed legends that explain what the reader is supposed to notice on the ultrasound scans. Instructor resources are available; please contact your Elsevier sales representative for details. * Detailed, labeled line drawings accompany most sonograms to provide reinforcement of what the student should notice on the scan. * 1,200 images spread over 528 pages ensure students gain a thorough, visual understanding of the field. * Introduction to Specialty Sonography section gives students an understanding of career options and an understanding of sonographers’ work in those areas. * Abdominal aorta, inf (more…)