Inspection of Medical Devices For Regulatory Purposes /

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,...

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Bibliographische Detailangaben
Körperschaft: SpringerLink (Online service)
Weitere Verfasser: Badnjević, Almir (HerausgeberIn), Cifrek, Mario (HerausgeberIn), Magjarević, Ratko (HerausgeberIn), Džemić, Zijad (HerausgeberIn)
Format: Elektronisch E-Book
Sprache:Englisch
Veröffentlicht: Cham : Springer Nature Switzerland : Imprint: Springer, 2024.
Ausgabe:2nd ed. 2024.
Schriftenreihe:Series in Biomedical Engineering,
Schlagworte:
Online-Zugang:https://doi.org/10.1007/978-3-031-43444-0
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Inhaltsangabe:
  • Introduction
  • Regulations and directives-Past, Present, Future
  • Legal metrology system-Past, Present, Future
  • Medical Device maintenance regimes in healthcare institutions
  • Post-Market Surveillance (PMS) of Medical Devices: From a Clinical Engineering Perspective
  • Application of Artificial Intelligence for management of maintenance and prediction of performances
  • Inspection and Testing of Electrocardiographs (ECG) Devices
  • Inspection and Testing of Noninvasive Blood Pressure Measuring Devices
  • Inspection and Testing of Diagnostic Ultrasound Devices
  • Inspection and Testing of Electroencephalographs, Electromyographs, and Evoked Response Equipment
  • Inspection and Testing of Defibrillators
  • Inspection and Testing of Mechanical Ventilators and Anaesthesia Machines
  • Inspection and Testing of Pediatric and Neonatal Incubators
  • Inspection and Testing of Infusion Pumps
  • Cost Effectiveness analysis of medical devices in legal metrology system
  • Cybersecurity, Data Protection, and Artificial Intelligence in Medical Devices.