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