eBook, PDF

Inspection of Medical Devices (eBook, PDF)

For Regulatory Purposes

Redaktion: Badnjevic, Almir; Dzemic, Zijad; Magjarevic, Ratko; Cifrek, Mario

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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!

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Almir Badnjevi¿ 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. 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 two years. Since 2016, he was appointed as a Board member of the IEEE Technical Committee for Cardiopulmonary Systems, while from 2020 he was appointed as Steering committee member of IEEE Standards. He has a mandate (2018 - 2024) to serve as Board Member of the Clinical Engineering Division of the International Federation of Medical and Biological Engineering (IFMBE) and mandate (2018 - 2022) to serve as Advisor for Regulatory Affairs and Treasurer of the European Alliance for Medical and Biological Engineering and Science (EAMBES). He served as IEEE standard coordinator for Region 8 (Europe, Middle East, Africa) in the period from 2019 - 2020. Additional he was appointed as Supervisory Board member at Privredna banka Sarajevo dd Sarajevo in the mandate 2019 - 2027. From 2021, he was appointed as IEEE EMBS Distinguished lecturer. He holds senior status at the IEEE organization. In 2016, his CV was recognized and included in the Marquis Who's Who in the World. In 2018, his team was awarded with IFMBE the best paper award in the field of clinical engineering, while in 2021 Verlab received IFMBE team award at the global level in the field of clinical engineering. In 2018, he was named "Person of the Year in Bosnia and Herzegovina" by SNL magazine, in 2020 he was named as "IN men of 2020" by Ladies In magazine, while he was named "CD person of 2020" by national Face TV. He is married and a father of two children. Mario Cifrek is Professor at the Department of Electronic Systems and Information Processing, Faculty of Electrical Engineering and Computing, University of Zagreb, Croatia. He has over 25 years of experience in Biomedical Engineering, both as University Teacher and as Researcher in scientific and R&D projects. Zijad Demi¿ has been General Manager of the Institute of Metrology of Bosnia and Herzegovina since 2010, Board of Directors Member of EURAMET (EU Cooperation in metrology) since 2013, Member of the Chair Group of WELMEC (EU Cooperation in legal metrology) since 2009, and Vice Chair of the Metrology Committee of Standards and Metrology Institute for the Islamic Countries (MC SMIIC) since 2013. In addition, he is Certified Technical Assessor for accreditation processes and procedures related to legal requirements, provisions of the New Approach, EC, and ISO regulations. Ratko Magjarevi¿ is Professor at the Faculty of Electrical Engineering and Computing, Department of Electronic Systems and Information Processing, University of Zagreb, Croatia. He has devoted more than 30 years to the research, development, and teaching of Biomedical Engineering. He has extensive international experience in leading projects and as Officer of international associations active in the field of Biomedical Engineering. He was Co-Editor (2006-2008) and has been Editor-in-Chief of the International Federation for Medical and Biological Engineering (IFMBE) Proceedings (ISSN 1680-0737) from 2009 to date.