[Discussion on Management Model of Medical Devices for Clinical Trials]

Zhongguo Yi Liao Qi Xie Za Zhi. 2020 Jan 8;44(1):88-91. doi: 10.3969/j.issn.1671-7104.2020.01.020.
[Article in Chinese]

Abstract

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.

Keywords: centralization; management model; medical devices clinical trials; medical devices used for clinical trials.

MeSH terms

  • Clinical Trials as Topic*
  • Equipment and Supplies / standards*
  • Indicators and Reagents / standards*
  • Reproducibility of Results
  • Research Design / standards*

Substances

  • Indicators and Reagents