Performance evaluation of in vitro diagnostic medical devices: Methodology and differences compared to studies on other medical devices-Reference-Cited by-同舟云学术

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Performance evaluation of in vitro diagnostic medical devices: Methodology and differences compared to studies on other medical devices

Published:2018-01 Issue: Volume:136 Page:279-282
ISSN:0026-265X
Container-title:Microchemical Journal
language:en
Short-container-title:Microchemical Journal

Author:

Grifa Rosa Anna,Pozzoli Giacomo

Publisher

Elsevier BV

Subject

Spectroscopy,Analytical Chemistry

Reference6 articles.

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. eur-lex.europa.eu›EUROPA›EU law and publications›EUR-Lex.

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. eur-lex.europa.eu›EUROPA›EU law and publications›EUR-Lex.

Cited by 3 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Accuracy of package inserts of SARS-CoV-2 rapid antigen tests: a secondary analysis of manufacturer versus systematic review data;The Lancet Microbe;2023-11

2. Methods and Advances in the Design, Testing and Development of In Vitro Diagnostic Instruments;Processes;2023-01-29

3. Regulatory context and validation of assays for clinical mass spectrometry proteomics (cMSP) methods;Critical Reviews in Clinical Laboratory Sciences;2018-05-23

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