Inspection of Medical Devices [electronic resource] : For Regulatory Purposes /
Contributor(s): Badnjević, Almir [editor.] | Cifrek, Mario [editor.] | Magjarević, Ratko [editor.] | Džemić, Zijad [editor.] | SpringerLink (Online service).
Series: Series in Biomedical Engineering: Publisher: Singapore : Springer Singapore : Imprint: Springer, 2018Edition: 1st ed. 2018.Description: VI, 289 p. 84 illus., 50 illus. in color. | Binding - Card Paper |.Content type: text Media type: computer Carrier type: online resourceISBN: 9789811066504.Subject(s): EXTC Engineering
| Biomedical Engineering and Bioengineering | Measurement Science and Instrumentation | Quality Control, Reliability, Safety and Risk | Medical LawDDC classification: 610.28 Online resources: Click here to access eBook in Springer Nature platform. (Within Campus only.)
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Springer Nature eBookSummary: 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.
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.
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