Inspection of Medical Devices

Presents processes, procedures and need for integrating medical devices into the legal realm, and for their independent verification

Offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations

Helps to increase the efficacy and reliability of patient diagnoses and treatment

Autorentext

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 Bihä, 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 Demi 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 Magjarevi 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.

Inhalt

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.