Advertisement

Inspection of Medical Devices

For Regulatory Purposes

  • Almir Badnjević
  • Mario Cifrek
  • Ratko Magjarević
  • Zijad Džemić

Part of the Series in Biomedical Engineering book series (BIOMENG)

Table of contents

  1. Front Matter
    Pages i-vi
  2. Almir Badnjević, Mario Cifrek, Ratko Magjarević, Zijad Džemić
    Pages 1-3
  3. Haris Memić, Almir Badnjević, Zijad Džemić
    Pages 5-29
  4. Alen Bošnjaković, Almir Badnjević, Zijad Džemić
    Pages 31-55
  5. Inspection and Testing of Diagnostic Devices

    1. Front Matter
      Pages 57-57
    2. Ratko Magjarević, Almir Badnjević
      Pages 59-79
    3. Gordana Žauhar, Ana Diklić, Slaven Jurković
      Pages 115-140
  6. Inspection and Testing of Therapeutic Devices

    1. Front Matter
      Pages 159-159
    2. Milan Ljubotina
      Pages 161-179
    3. Dušanka Bošković
      Pages 203-220
    4. Lejla Gurbeta, Sebija Izetbegović, Alma Badnjević-Čengić
      Pages 221-249
    5. Ernesto Iadanza, Diletta Pennati, Fabrizio Dori
      Pages 251-269

About this book

Introduction

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.

Keywords

Medical Device Verification Medical Device Inspection Accreditation ECG Devices Defibrillators Patient Monitors Anaesthesia Machines Dialysis Machines Neonate Incubators EMG Devices EEG Devices Telemedicine Inspection

Editors and affiliations

  • Almir Badnjević
    • 1
  • Mario Cifrek
    • 2
  • Ratko Magjarević
    • 3
  • Zijad Džemić
    • 4
  1. 1.Verlab Ltd SarajevoMedical Devices Verification LaboratorySarajevoBosnia and Herzegovina
  2. 2.Faculty of Electrical Engineering and Computing ZagrebUniversity of ZagrebZagrebCroatia
  3. 3.Faculty of Electrical Engineering and Computing ZagrebUniversity of ZagrebZagrebCroatia
  4. 4.Institute of Metrology of Bosnia and HerzegovinaSarajevoBosnia and Herzegovina

Bibliographic information

  • DOI https://doi.org/10.1007/978-981-10-6650-4
  • Copyright Information Springer Nature Singapore Pte Ltd. 2018
  • Publisher Name Springer, Singapore
  • eBook Packages Engineering
  • Print ISBN 978-981-10-6649-8
  • Online ISBN 978-981-10-6650-4
  • Series Print ISSN 1864-5763
  • Buy this book on publisher's site