Inspection of Medical Devices
Beschreibung:
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 Bihac, and an industry expert at the Faculty of Electrical Engineering, University of Sarajevo. In addition to serving as an international consultant for Medical Devices, he is a 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), Founder and Chair of the IEEE/IFMBE CMBEBIH Conference. He is the author of more than 60 book chapters, journal articles, and conference papers.
Mario Cifrek is a 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 a university teacher and as a researcher in scientific and R&D projects.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, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations.
Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Introduction.- Regulations and Directives - past, present, future.- Legal Metrology System - past, present, future.- Inspection of Diagnostic Medical Devices.- Inspection of Therapeutic Medical Devices.- Telemedicine Procedures.- Conclusion.