Inspection of medical devices : for regulatory purposes 1st ed.

Author

Additional Author(s)

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

Publisher

Singapore: Springer Nature Singapore Pte Ltd., 2018

Language

English

ISBN

9789811066504

Series

Series in Biomedical Engineering

Subject(s)

• MEDICAL LAWS AND LEGISLATION
• PHYSICAL MEASUREMENTS
• QUALITY CONTROL

Notes

. .

Abstract

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.

Physical Dimension

Number of Page(s)

1 online resource (vi, 289 p.)

Dimension

-

Other Desc.

ill. (in col.)

Summary / Review / Table of Content

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.

Exemplar(s)

#	Accession No.	Call Number	Location	Status
1.	00781/20	681.7610287 Ins	Online !	Available