省药监局审评中心组织审评员赴苏州开展无源类医疗器械实训

时间:2020-11-11

 为进一步加强(qiang)医疗(liao)(liao)(liao)器(qi)(qi)械(xie)审(shen)评(ping)(ping)能力(li)建设,帮助(zhu)审(shen)评(ping)(ping)员更新知识和提升(sheng)审(shen)评(ping)(ping)能力(li),根据(ju)年(nian)度培训(xun)计划安排,近日(ri),省药监局审(shen)评(ping)(ping)中(zhong)心(xin)组(zu)织无源(yuan)组(zu)医疗(liao)(liao)(liao)器(qi)(qi)械(xie)审(shen)评(ping)(ping)员赴(fu)苏州两家医疗(liao)(liao)(liao)器(qi)(qi)械(xie)生(sheng)产企(qi)业开展驻厂实训(xun)。实训(xun)主要针对介入类(lei)(lei)无源(yuan)医疗(liao)(liao)(liao)器(qi)(qi)械(xie),重(zhong)点围绕微导(dao)(dao)管导(dao)(dao)丝系(xi)统、亲水涂层导(dao)(dao)丝、造影导(dao)(dao)管、外周(zhou)球(qiu)囊扩张导(dao)(dao)管等(deng)产品进行学习。审(shen)评(ping)(ping)员在实训(xun)中(zhong)对该类(lei)(lei)产品的(de)(de)工(gong)(gong)作(zuo)原理、结构设计、生(sheng)产工(gong)(gong)艺(yi)、临床使(shi)用(yong)等(deng)环节(jie)进行了(le)系(xi)统的(de)(de)学习,针对每(mei)一道工(gong)(gong)序所用(yong)设备(bei)参(can)数、工(gong)(gong)艺(yi)优缺点、质控难点与企(qi)业人员进行研讨(tao)交流(liu)。通(tong)过(guo)实训(xun),使(shi)审(shen)评(ping)(ping)员深入了(le)解(jie)了(le)介入类(lei)(lei)医疗(liao)(liao)(liao)器(qi)(qi)械(xie)的(de)(de)研制、生(sheng)产、体系(xi)管理过(guo)程,为后续做好此类(lei)(lei)产品的(de)(de)技(ji)术审(shen)评(ping)(ping)工(gong)(gong)作(zuo)积累(lei)了(le)实践(jian)经验。





(医疗器械一科)