(Ebook PDF) Inspection of Medical Devices 1st edition by Almir Badnjević 9811066507 9789811066504 full chapters

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Product details:

ISBN-10 ‏ : ‎9811066507 

ISBN-13 ‏ : ‎ 9789811066504

Author :  Almir Badnjević 

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.

 Inspection of Medical Devices 1st Table of contents:

1 Introduction
2 Placing of Medical Devices in the Market of EU in Accordance with EU Legislation
3 EU Legislation in the Field of Medical Devices
4 Notified Bodies for Conformity Assessment According to Directive 93/42/EEC
5 Conformity Assessment of Medical Devices
6 Standards Used in Manufacturing Process of Medical Devices
7 Conformity Assessment in Accordance with Requirements in the USA
8 International Organisation for Health
9 Medicine in the Field of Legal Metrology

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