CAJ | 학술논문

该文通过分析中山大学附属第三医院近10年完成的医疗器械临床试验的一般资料，结合临床试验过程中的管理经验，对我院医疗器械临床试验的特点及存在问题进行阐述，并提出相应的管理对策以保证医疗器械试验的质量，提高医院对医疗器械临床试验管理的规范性。
해문통과분석중산대학부속제삼의원근10년완성적의료기계림상시험적일반자료，결합림상시험과정중적관리경험，대아원의료기계림상시험적특점급존재문제진행천술，병제출상응적관리대책이보증의료기계시험적질량，제고의원대의료기계림상시험관리적규범성。
In this paper, we analyse the general information of medical equipment clinical trials by clinical trial process management experience to elaborate the characteristics of the medical equipment clinical trials and the existent problems in our hospital in 10 years. We propose corresponding countermeasures to ensure the quality of medical tests, and improve the management of medical equipment clinical trials in hospital.