Inspection of Medical Devices For Regulatory Purposes
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, a
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Almir Badnjević Mario Cifrek · Ratko Magjarević Zijad Džemić Editors
Inspection of Medical Devices For Regulatory Purposes
Series in Biomedical Engineering Series editor Joachim H. Nagel, Stuttgart, Germany
This series describes the applications of physical science, engineering and mathematics in medicine and biology. The books are written for graduate students and researchers in many disciplines including medical physics, biomedical engineering, radiology, radiotherapy and clinical research. The Series in Biomedical Engineering is the official book series of the International Federation for Medical and Biological Engineering. The IFMBE is an association of constituent societies and organizations which was established in 1959 to encourage and promote international collaboration in research and practice of the profession as well as in the management of technology and the use of science and engineering in medicine and biology for improving health and quality of life. Its activities include participation in the formulation of public policy and the dissemination of information through publications and forums. The IFMBE as the only international organization and WHO/UN accredited NGO covering the full range of biomedical/clinical engineering, healthcare, and healthcare technology management, represents through its 50 national and international member societies more than 120.000 professionals involved in the issues of improved health care delivery. The IFMBE is associated with the International Union for Physical and Engineering Sciences in Medicine (IUPESM). Through the IUPESM, the IFMBE is a member of the International Council for Science (ICSU). http://www.ifmbe.org
More information about this series at http://www.springer.com/series/7752
Almir Badnjević Mario Cifrek Ratko Magjarević Zijad Džemić •
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Editors
Inspection of Medical Devices For Regulatory Purposes
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Editors Almir Badnjević Medical Devices Verification Laboratory Verlab Ltd Sarajevo Sarajevo Bosnia and Herzegovina Mario Cifrek Faculty of Electrical Engineering and Computing University of Zagreb Zagreb Croatia
Ratko Magjarević Faculty of Electrical Engineering and Computing University of Zagreb Zagreb Croatia Zijad Džemić Institute of Metrology of Bosnia and Herzegovina Sarajevo Bosnia and Herzegovina
ISSN 1864-5763 Series in Biomedical Engineering ISBN 978-981-10-6649-8 ISBN 978-981-10-6650-4 https://doi.org/10.1007/978-981-10-6650-4
(eBook)
Library of Congress Control Number: 2017954478 © Springer Nature Singapore Pte Ltd. 2018 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, t
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