Inspection of Medical Devices
For Regulatory Purposes
(Sprache: Englisch)
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...
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Klappentext zu „Inspection of Medical Devices “
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
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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!
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Inhaltsverzeichnis zu „Inspection of Medical Devices “
Introduction.- Regulations and directives-Past, Present, Future.- Legal metrology system-Past, Present, Future.- Medical Device maintenance regimes in healthcare institutions.- Post-Market Surveillance (PMS) of Medical Devices: From a Clinical Engineering Perspective.- Application of Artificial Intelligence for management of maintenance and prediction of performances.- Inspection and Testing of Electrocardiographs (ECG) Devices.- Inspection and Testing of Noninvasive Blood Pressure Measuring Devices.- Inspection and Testing of Diagnostic Ultrasound Devices.- Inspection and Testing of Electroencephalographs, Electromyographs, and Evoked Response Equipment.- Inspection and Testing of Defibrillators.- Inspection and Testing of Mechanical Ventilators and Anaesthesia Machines.- Inspection and Testing of Pediatric and Neonatal Incubators.- Inspection and Testing of Infusion Pumps.- Cost Effectiveness analysis of medical devices in legal metrology system.- Cybersecurity, Data Protection, and Artificial Intelligence in Medical Devices.
Autoren-Porträt
Almir Badnjevic was born in 1986 in Bosanska Krupa, Bosnia and Herzegovina. He received his PhD from the Faculty of Electrical Engineering and Computing Zagreb (FER), University of Zagreb in 2015. Since 2008, he is working in two spheres, business and academia. In the period from 2010 to 2014, he worked in the industry of medical devices, metrology, standards and big data processing. He is one of the founders of the idea of including medical devices with the measuring function into legal metrology framework and the establishment of measurement traceability in medical measurements globally. On that idea, in 2014, he established one of the most equipped laboratories for testing and verification of medical devices in Europe, the Verlab laboratory. The main task of Verlab is to perform annual verification of safety and performances of medical devices in all healthcare institutions of Bosnia and Herzegovina in accordance with the ISO 17020 standard. Based on the experience gained in this field, as one of the editors he wrote a book "Inspection of medical devices - for regulatory purposes" which was published by Springer Nature. In the past, he was an advisor in more than 20 Ministries of Health worldwide in the field of medical devices.In 2022, Verlab company established the first private Research Institute in Bosnia and Herzegovina, named Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence. In less than one years, this Institute established collaborations with institutions such as CERN, Fraunhofer, Helmholtz and participate in few international projects in the field of high-performance computing, artificial intelligence and medical devices. Verlab Institute is a candidate to become a global Collaborative Center of WHO.
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In 2023, by Council of Ministers decision, he is appointed as director of Agency for identification documents, registers and data exchange of Bosnia and Herzegovina in the mandate 2023 - 2028.In his academic career, since 2015, he has been working as head of the Department of Genetics and Bioengineering at the Faculty of Engineering and Natural Sciences, International Burch University. He established the first Master and PhD program of Bioengineering in Bosnia and Herzegovina. At the International Burch University, today he holds Full Professor position in the field of Bioengineering, while at University of Sarajevo he holds Associate Professor position in the field of Healthcare Informatics. Since 2015 he has been working as an expert in practice at the University of Warwick (UK) too. He is the author or co-author of over 150 chapters of the books, books, journal articles and international conference articles. He is included in top 2% world scientists by Elsevier and Stanford University list.
In 2021, he became a regular member of the International Academy of Sciences and Arts in Bosnia and Herzegovina (IANUBIH) and Ordinary member of European Academy of Sciences and Arts, while in 2023 he became a Fellow of World Academy of Art and Science.
In 2022, he was named as Editor in Chief of Technology and Health Care Journal published by IOS press and Associate Editor of Springer's Health and Technology Journal and Springer Nature BioMedical Engineering OnLine Journal.Besides the academic and business sectors, he gained professional experience through nongovernment organizations. In 2014, as one of the founders and elected president, he established Bosnia and Herzegovina Medical and Biological Engineering Society, which is the country representative in IFMBE and EAMBES.
In 2021, this Society established LabHub which became EU DIH (European Digital Innovation Hub).
Since 2015, this Society, for the first time in the history of country began organizing the International Conference on Medical and Biological Engineering (CMBEBIH), which brings together an average of over 700 participants from about 40 countries every tw
In 2023, by Council of Ministers decision, he is appointed as director of Agency for identification documents, registers and data exchange of Bosnia and Herzegovina in the mandate 2023 - 2028.In his academic career, since 2015, he has been working as head of the Department of Genetics and Bioengineering at the Faculty of Engineering and Natural Sciences, International Burch University. He established the first Master and PhD program of Bioengineering in Bosnia and Herzegovina. At the International Burch University, today he holds Full Professor position in the field of Bioengineering, while at University of Sarajevo he holds Associate Professor position in the field of Healthcare Informatics. Since 2015 he has been working as an expert in practice at the University of Warwick (UK) too. He is the author or co-author of over 150 chapters of the books, books, journal articles and international conference articles. He is included in top 2% world scientists by Elsevier and Stanford University list.
In 2021, he became a regular member of the International Academy of Sciences and Arts in Bosnia and Herzegovina (IANUBIH) and Ordinary member of European Academy of Sciences and Arts, while in 2023 he became a Fellow of World Academy of Art and Science.
In 2022, he was named as Editor in Chief of Technology and Health Care Journal published by IOS press and Associate Editor of Springer's Health and Technology Journal and Springer Nature BioMedical Engineering OnLine Journal.Besides the academic and business sectors, he gained professional experience through nongovernment organizations. In 2014, as one of the founders and elected president, he established Bosnia and Herzegovina Medical and Biological Engineering Society, which is the country representative in IFMBE and EAMBES.
In 2021, this Society established LabHub which became EU DIH (European Digital Innovation Hub).
Since 2015, this Society, for the first time in the history of country began organizing the International Conference on Medical and Biological Engineering (CMBEBIH), which brings together an average of over 700 participants from about 40 countries every tw
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Bibliographische Angaben
- 2023, 2. Aufl., VI, 445 Seiten, 58 farbige Abbildungen, Masse: 15,5 x 23,5 cm, Gebunden, Englisch
- Herausgegeben: Almir Badnjevic, Mario Cifrek, Ratko Magjarevic, Zijad Dzemic
- Verlag: Springer, Berlin
- ISBN-10: 3031434439
- ISBN-13: 9783031434433
Sprache:
Englisch
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