Inspection of Medical Devices For Regulatory Purposes /

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Badnjević, Almir (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Cifrek, Mario (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Magjarević, Ratko (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Džemić, Zijad (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Singapore : Springer Singapore : Imprint: Springer, 2018.
• Έκδοση: 1st ed. 2018.
• Σειρά: Series in Biomedical Engineering,
• Θέματα: Biomedical engineering.; Physical measurements.; Measurement .; Quality control.; Reliability.; Industrial safety.; Medical laws and legislation.; Biomedical Engineering and Bioengineering.; Measurement Science and Instrumentation.; Quality Control, Reliability, Safety and Risk.; Biomedical Engineering/Biotechnology.; Medical Law.

 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. 

 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.