Inspection of Medical Devices

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Publisher : Springer Nature
ISBN 13 : 3031434447
Total Pages : 441 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Inspection of Medical Devices by : Almir Badnjević

Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS

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Author :
Publisher : CHETAN KATHALAY
ISBN 13 :
Total Pages : 157 pages
Book Rating : 4./5 ( download)

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Book Synopsis CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS by : CHETAN KATHALAY

Download or read book CE MARKING BOOK -OF ELECTRICAL AND ELECTRONIC PRODUCTS written by CHETAN KATHALAY and published by CHETAN KATHALAY. This book was released on 2020-06-03 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Buy CE marking book in India.This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.

Medical Instrument Design and Development

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118652460
Total Pages : 600 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Medical Instrument Design and Development by : Claudio Becchetti

Download or read book Medical Instrument Design and Development written by Claudio Becchetti and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref="http://www.gammacardiosoft.it/book"www.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.

Neurorehabilitation Technology

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Publisher : Springer
ISBN 13 : 331928603X
Total Pages : 647 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Neurorehabilitation Technology by : David J. Reinkensmeyer

Download or read book Neurorehabilitation Technology written by David J. Reinkensmeyer and published by Springer. This book was released on 2016-08-03 with total page 647 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.

Federal Register

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Author :
Publisher :
ISBN 13 :
Total Pages : 426 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Federal Register by :

Download or read book Federal Register written by and published by . This book was released on 2014 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Advances in Electrocardiograms

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Author :
Publisher : BoD – Books on Demand
ISBN 13 : 9533079231
Total Pages : 406 pages
Book Rating : 4.5/5 (33 download)

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Book Synopsis Advances in Electrocardiograms by : Richard Millis

Download or read book Advances in Electrocardiograms written by Richard Millis and published by BoD – Books on Demand. This book was released on 2012-01-25 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt: Electrocardiograms are one of the most widely used methods for evaluating the structure-function relationships of the heart in health and disease. This book is the first of two volumes which reviews recent advancements in electrocardiography. This volume lays the groundwork for understanding the technical aspects of these advancements. The five sections of this volume, Cardiac Anatomy, ECG Technique, ECG Features, Heart Rate Variability and ECG Data Management, provide comprehensive reviews of advancements in the technical and analytical methods for interpreting and evaluating electrocardiograms. This volume is complemented with anatomical diagrams, electrocardiogram recordings, flow diagrams and algorithms which demonstrate the most modern principles of electrocardiography. The chapters which form this volume describe how the technical impediments inherent to instrument-patient interfacing, recording and interpreting variations in electrocardiogram time intervals and morphologies, as well as electrocardiogram data sharing have been effectively overcome. The advent of novel detection, filtering and testing devices are described. Foremost, among these devices are innovative algorithms for automating the evaluation of electrocardiograms.

Handbook of Human Factors in Medical Device Design

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Author :
Publisher : CRC Press
ISBN 13 : 1420063510
Total Pages : 822 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Human Factors in Medical Device Design by : Matthew Bret Weinger

Download or read book Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Medical Device

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Publisher : Xlibris Corporation
ISBN 13 : 1524589209
Total Pages : 403 pages
Book Rating : 4.5/5 (245 download)

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Book Synopsis Medical Device by : Rommel Garcia

Download or read book Medical Device written by Rommel Garcia and published by Xlibris Corporation. This book was released on 2017-06-06 with total page 403 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.

Compliance Engineering

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Author :
Publisher :
ISBN 13 :
Total Pages : 176 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Compliance Engineering by :

Download or read book Compliance Engineering written by and published by . This book was released on 2006 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Wearable/Personal Monitoring Devices Present to Future

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Author :
Publisher : Springer Nature
ISBN 13 : 9811653240
Total Pages : 298 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Wearable/Personal Monitoring Devices Present to Future by : Gaetano D. Gargiulo

Download or read book Wearable/Personal Monitoring Devices Present to Future written by Gaetano D. Gargiulo and published by Springer Nature. This book was released on 2021-10-26 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses recent advances in wearable technologies and personal monitoring devices, covering topics such as skin contact-based wearables (electrodes), non-contact wearables, the Internet of things (IoT), and signal processing for wearable devices. Although it chiefly focuses on wearable devices and provides comprehensive descriptions of all the core principles of personal monitoring devices, the book also features a section on devices that are embedded in smart appliances/furniture, e.g. chairs, which, despite their limitations, have taken the concept of unobtrusiveness to the next level. Wearable and personal devices are the key to precision medicine, and the medical community is finally exploring the opportunities offered by long-term monitoring of physiological parameters that are collected during day-to-day life without the bias imposed by the clinical environment. Such data offers a prime view of individuals’ physical condition, as well as the efficacy of therapy and occurrence of events. Offering an in-depth analysis of the latest advances in smart and pervasive wearable devices, particularly those that are unobtrusive and invisible, and addressing topics not covered elsewhere, the book will appeal to medical practitioners and engineers alike.

Biomedical Engineering Design

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Publisher : Academic Press
ISBN 13 : 0128166258
Total Pages : 529 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biomedical Engineering Design by : Joseph Tranquillo

Download or read book Biomedical Engineering Design written by Joseph Tranquillo and published by Academic Press. This book was released on 2022-02-19 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. - Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods - Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process - Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions - Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for 'X', and incorporating standards and design controls - Discusses topics that prepare students for careers in medical device design or other related medical fields

Computer Recognition Systems

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Publisher : Springer Science & Business Media
ISBN 13 : 3540323902
Total Pages : 895 pages
Book Rating : 4.5/5 (43 download)

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Book Synopsis Computer Recognition Systems by : Marek Kurzynski

Download or read book Computer Recognition Systems written by Marek Kurzynski and published by Springer Science & Business Media. This book was released on 2007-12-13 with total page 895 pages. Available in PDF, EPUB and Kindle. Book excerpt: th This book contains papers accepted for presentation at the 4 International Conference on Computer Recognition Systems CORES'05, May 22-25, 2005, Rydzyna Castle (Poland), This conference is a continuation of a series of con ferences on similar topics (KOSYR) organized each second year, since 1999, by the Chair of Systems and Computer Networks, Wroclaw University of Tech nology. An increasing interest to those conferences paid not only by home but also by foreign participants inspired the organizers to transform them into conferences of international range. Our expectations that the community of specialists in computer recognizing systems will find CORES'05 a proper form of maintaining the tradition of the former conferences have been confirmed by a large number of submitted papers. Alas, organizational constraints caused a necessity to narrow the acceptance criteria so that only 100 papers have been finally included into the conference program. The area covered by accepted papers is still very large and it shows how vivacious is scientific activity in the domain of computer recognition methods and systems. It contains vari ous theoretical approaches to the recognition problem based on mathematical statistics, fuzzy sets, morphological methods, wavelets, syntactic methods, genetic algorithms, artificial neural networks, ontological models, etc. Most attention is still paid to visual objects recognition; however, acoustic, tex tual and other objects are also considered. Among application areas medical problems are in majority; recognition of faces, speech signals and textual in formation processing methods being also investigated.

Design and Development of Medical Electronic Instrumentation

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Publisher : John Wiley & Sons
ISBN 13 : 0471681830
Total Pages : 479 pages
Book Rating : 4.4/5 (716 download)

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Book Synopsis Design and Development of Medical Electronic Instrumentation by : David Prutchi

Download or read book Design and Development of Medical Electronic Instrumentation written by David Prutchi and published by John Wiley & Sons. This book was released on 2005-01-28 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.

Developments and Applications for ECG Signal Processing

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Publisher : Academic Press
ISBN 13 : 0128140364
Total Pages : 212 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Developments and Applications for ECG Signal Processing by : Joao Paulo do Vale Madeiro

Download or read book Developments and Applications for ECG Signal Processing written by Joao Paulo do Vale Madeiro and published by Academic Press. This book was released on 2018-11-29 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developments and Applications for ECG Signal Processing: Modeling, Segmentation, and Pattern Recognition covers reliable techniques for ECG signal processing and their potential to significantly increase the applicability of ECG use in diagnosis. This book details a wide range of challenges in the processes of acquisition, preprocessing, segmentation, mathematical modelling and pattern recognition in ECG signals, presenting practical and robust solutions based on digital signal processing techniques. Users will find this to be a comprehensive resource that contributes to research on the automatic analysis of ECG signals and extends resources relating to rapid and accurate diagnoses, particularly for long-term signals. Chapters cover classical and modern features surrounding f ECG signals, ECG signal acquisition systems, techniques for noise suppression for ECG signal processing, a delineation of the QRS complex, mathematical modelling of T- and P-waves, and the automatic classification of heartbeats. - Gives comprehensive coverage of ECG signal processing - Presents development and parametrization techniques for ECG signal acquisition systems - Analyzes and compares distortions caused by different digital filtering techniques for noise suppression applied over the ECG signal - Describes how to identify if a digitized ECG signal presents irreversible distortion through analysis of its frequency components prior to, and after, filtering - Considers how to enhance QRS complexes and differentiate these from artefacts, noise, and other characteristic waves under different scenarios

Sensors, Signal and Image Processing in Biomedicine and Assisted Living

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Publisher : MDPI
ISBN 13 : 3039434187
Total Pages : 312 pages
Book Rating : 4.0/5 (394 download)

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Book Synopsis Sensors, Signal and Image Processing in Biomedicine and Assisted Living by : Dimitris K. Iakovidis

Download or read book Sensors, Signal and Image Processing in Biomedicine and Assisted Living written by Dimitris K. Iakovidis and published by MDPI. This book was released on 2020-11-04 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a collection of recent advances on sensors, systems, and signal/image processing methods for biomedicine and assisted living. It includes methods for heart, sleep, and vital sign measurement; human motion-related signal analysis; assistive systems; and image- and video-based diagnostic systems. It provides an overview of the state-of-the-art challenges in the respective topics and future directions. This will be useful for researchers in various domains, including computer science, electrical engineering, biomedicine, and healthcare researchers.

Wearable Devices for Cardiac Rhythm Monitoring, Volume II

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Author :
Publisher : Frontiers Media SA
ISBN 13 : 2832546129
Total Pages : 103 pages
Book Rating : 4.8/5 (325 download)

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Book Synopsis Wearable Devices for Cardiac Rhythm Monitoring, Volume II by : Emma Svennberg

Download or read book Wearable Devices for Cardiac Rhythm Monitoring, Volume II written by Emma Svennberg and published by Frontiers Media SA. This book was released on 2024-03-14 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Research Topic is the second volume of the “Wearable Devices for Cardiac Rhythm Monitoring: Vol II”. Please see the first volume here.New wearable technologies for cardiac rhythm monitoring are gaining more and more importance in clinical routine in the field of cardiology and electrophysiology - by physicians as well as patients. These include, but are by far not restricted to smartphone-based ECG or PPG, finger-ECG, smartwatches, smart garments and more. This opens new horizons for mHealth-based patient care, mHealth-enhanced teleconsultations, but also mass screening for heart rhythm disorders.The proposed Research Topic aims to present new research on these technologies covering methodological aspects on wearable single- and multiple-lead ECG or photophlethysmography devices, (mass) screening for atrial fibrillation or other arrhythmias with new devices, implementation of mHealth into clinical pathways of cardiac diseases, short or long-term telemonitoring through wearables devices, cost-effectiveness, and more.

2008 Healthcare Standards Official Directory

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Author :
Publisher : Ecri
ISBN 13 : 9780977914272
Total Pages : 3384 pages
Book Rating : 4.9/5 (142 download)

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Book Synopsis 2008 Healthcare Standards Official Directory by : ECRI Institute Staff

Download or read book 2008 Healthcare Standards Official Directory written by ECRI Institute Staff and published by Ecri. This book was released on 2007-12 with total page 3384 pages. Available in PDF, EPUB and Kindle. Book excerpt: