Inspection of medical devices : for regulatory purposes / Almir Badnjević, Mario Cifrek, Ratko Magjarević, Zijad Džemić, editors.
2018
R856.4
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Details
Title
Inspection of medical devices : for regulatory purposes / Almir Badnjević, Mario Cifrek, Ratko Magjarević, Zijad Džemić, editors.
ISBN
9789811066504 (electronic book)
9811066507 (electronic book)
9789811066498
9811066507 (electronic book)
9789811066498
Published
Singapore : Springer, [2018]
Language
English
Description
1 online resource.
Item Number
10.1007/978-981-10-6650-4 doi
Call Number
R856.4
Dewey Decimal Classification
681/.7610287
Summary
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.
Access Note
Access limited to authorized users.
Digital File Characteristics
text file PDF
Source of Description
Online resource; title from PDF title page (viewed November 1, 2017).
Added Author
Badnjevic, Almir, editor.
Cifrek, Mario, editor.
Magjarević, Ratko, editor.
Džemić, Zijad, editor.
Cifrek, Mario, editor.
Magjarević, Ratko, editor.
Džemić, Zijad, editor.
Series
Series in biomedical engineering.
Available in Other Form
Print version: 9789811066498
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Online Access
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Table of Contents
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.
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.