Badnjević Inspection of Medical Devices

Inspection of Medical Devices

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For Regulatory Purposes

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Beschreibung

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.


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


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 Includes supplementary material: sn.pub/extras

Autor*in

Almir Badnjević

Themen in »Inspection of Medical Devices«

Medical Device Verification Medical Device Inspection Accreditation ECG Devices Defibrillators Patient Monitors Anaesthesia Machines Dialysis Machines Neonate Incubators EMG Devices EEG Devices Telemedicine Inspection quality control, reliability, safety and risk

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Details

ISBN: 9789811066504
Verlag: Springer Singapore
Erscheinung: 26.10.2017

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