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 conformity assessment of performance characteristics.
Authors
- Volodymyr Maslennikov (ORCID: https://orcid.org/0000-0003-2195-3698)
Institutions
- Scientific Research Institute of Healthcare Organization and Medical Management (RU)
Publication Details
- Journal
- City Healthcare
- Published
- 2024-12-26
- DOI
- https://doi.org/10.47619/2713-2617.zm.2024.v.5i4p1;142-161
- Primary Topic
- Quality and Safety in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 0.00