培训邀请 I 欧盟MD临床评估专项培训
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李尹 Vanlee
普瑞纯证高级项目工程师
主要项目经验:
十年以上医疗器械及体外诊断海外注册经验,超千份海外注册技术文档撰写与体系辅导经验
领导完成中国首个、全球第二个含药创可贴 FDA 510(k) 注册,以及多项FDA EUA新冠抗原、核酸与猴痘抗原、核酸注册
主持数十个IVDD Self-Test和List A项目(新冠、乙肝、丙肝、艾滋等),以及多个MDR IIb、三类高风险器械项目,多个IVDR高风险上呼吸道感染欧盟临床项目
拥有数十项欧美临床获证经验、多项全球多中心临床经验与海外临床NMPA获证经验,以及欧美血糖相关MD产品注册临床项目经验
拥有丰富的ISO 13485体系、QSR 820辅导经验
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