A Brief Analysis of Equivalence Demonstration Techniques for Clinical Evaluation of Medical Devices
This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products ex...
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| Published in | Zhongguo yi liao qi xie za zhi Vol. 47; no. 3; p. 328 |
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| Main Authors | , , , , |
| Format | Journal Article |
| Language | Chinese |
| Published |
China
30.05.2023
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| Subjects | |
| Online Access | Get full text |
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| Abstract | This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues. |
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| AbstractList | This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues. This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues.This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration |
| Author | Wu, Sujing Liang, Yu Ji, Chengxue Tian, Huanhuan Wang, Weili |
| Author_xml | – sequence: 1 givenname: Huanhuan surname: Tian fullname: Tian, Huanhuan organization: Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299 – sequence: 2 givenname: Sujing surname: Wu fullname: Wu, Sujing organization: Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299 – sequence: 3 givenname: Yu surname: Liang fullname: Liang, Yu organization: Shanghai Bisheng Consulting Co. Ltd., Shanghai, 201413 – sequence: 4 givenname: Weili surname: Wang fullname: Wang, Weili organization: Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299 – sequence: 5 givenname: Chengxue surname: Ji fullname: Ji, Chengxue organization: Shanghai Bisheng Consulting Co. Ltd., Shanghai, 201413 |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37288639$$D View this record in MEDLINE/PubMed |
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| Title | A Brief Analysis of Equivalence Demonstration Techniques for Clinical Evaluation of Medical Devices |
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