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…)

Offers the protection of the CPR Microshield with the convenience of a keychain. Patented one-way valve assures the rescuer that the barrier will not leak or fall apart during CPR. Enclosed in a durable nylon key ring pouch with hook and loop closure. Black.

(more…)

There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources. After reading this book, individuals involved in medical product development, (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…)

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

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 Second Edition, this practical guide continues to be the benchmark for incorporating relia (more…)