Regulatory Use of Essential Performance Characteristics of Medical Devices for In Vitro Diagnostics

The article covers the performance characteristics of in vitro diagnostics (IVD) medical devices, the systematic approaches to specify the performance characteristics of IVD medical devices, the review of regulations with specified performance characteristics, and the methods of validation and confo...

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Bibliographic Details
Main Author: V. V. Maslennikov
Format: Article
Language:Russian
Published: Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department 2024-12-01
Series:Здоровье мегаполиса
Subjects:
Online Access:https://www.city-healthcare.com/jour/article/view/159
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