Inspection of Medical Devices: For Regulatory Purposes

ISBN-13: 9783031434433 / Angielski

Almir Badnjevic; Mario Cifrek; Ratko Magjarevic

Spis treści

1. Introduction - Badnjevic, Cifrek, Magjarevic, Dzemic

2. Regulations and Directives - Past, present, future - Memic, Badnjevic, Dzemic

3. Legal Metrology System - Past, present, future - Bosnjakovic, Badnjevic, Dzemic

4. Medical Device maintenance regimes in healthcare institutions - Daniel Clark

5. Post-market surveillance of medical devices - Tom Judd

6. Application of AI for managment maintenance and prediction of performances - Gurbeta Pokvic, Deumic, Badnjevic

Inspection and Testing of Diagnostic Devices

7.. Inspection and Testing of ECG devices - Magjarevic, Badnjevic

8. Inspection and Testing of Noninvasive Blood Pressure Measuring Devices - Lackovic

9. Inspection and Testing of Diagnostic Ultrasound Devices - Zauhar, Diklic, Jurkovic

10. Inspection and testing of EEG, EMG and ER Equipment - Cifrek, Luka Jelic

Inspection and Testing of Therapeutic Devices

11. Inspection and Testing of Defibrillators - Ljubotina

12. Inspection and Testing of Mechnical Ventilators and Anaesthesia Machines - Karaboce

13. Inspection and Testing of Dialysis Machines - Boskovic

14. Inspection and Testing of Pediatric and Neonate Incubators - Gurbeta Pokvic, Badnjevic Cengic

15. Inspection and Testing of Infusion Pumps - Iadanza

16. Cost Effectiveness analysis of medical devices in legal metrology system - Vukovic, Badnjevic

O autorze

Almir Badnjevic is Director of the Medical Devices Verification Laboratory VERLAB, Sarajevo, Bosnia, and Herzegovina; Assistant Professor and Head of the Department of Genetics and Bioengineering at the International Burch University, Sarajevo; Assistant Professor at the Faculty of Technical Engineering, University of Bihać; and Industry Expert at the Faculty of Electrical Engineering, University of Sarajevo. In addition to serving as International Consultant for Medical Devices, he is Board Member of ESEM (Educating Students in Engineering and Medicine), President of the Bosnia and Herzegovina Medical and Biological Engineering Society (International Federation for Medical and Biological Engineering, IFMBE Member), and Founder and Chair of the IEEE/IFMBE CMBEBIH Conference. He is Author of more than 60 chapters, journal articles, and conference papers.

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 Džemić 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 Magjarević 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.

Blurb

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!