Inspection of Medical Devices: For Regulatory Purposes

ISBN-13: 9789811349232 / Angielski / Miękka / 2019 / 289 str.

Almir Badnjevic; Mario Cifrek; Ratko Magjarevic

Spis treści

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.

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 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. 

Zijad Džemić has been the 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 a Certified Technical Assessor for accreditation processes and procedures related to legal requirements, provisions of the New Approach, EC and ISO regulations.

Ratko Magjarević is a 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 an officer of international associations active in the field of Biomedical Engineering. He was the Co-Editor (2006–2008) and has been the Editor-in-Chief of the International Federation for Medical and Biological Engineering (IFMBE) Proceedings (ISSN 1680-0737) from 2009 to date.

Blurb

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.