完成wallstent的延续其他文件，除了检测报告之外的其他。（Due date: 16/04/2018）

yegao0427 / srs

0 stars 0 forks source link

Closed yegao0427 closed 6 years ago

yegao0427 commented 6 years ago

02 证明性文件- 营业执照缺失

05 分析报告--需要找amy 去要国外的临床反馈

06 检验报告-- 需要问如何去order sample

08 其他--技术要求对比表产品注册标准

yegao0427 commented 6 years ago

怎么去做公证？发送给谁，大约需要多久的时间？

yegao0427 commented 6 years ago

等待小贝的标签和说明书。还有这周和小元讨论怎么写产品分析报告。

接下来的事情：

递交申请。

yegao0427 commented 6 years ago

two problems occured:

Content of EO residual has been mentioned in the techinical requirement doc, but the actual sterilization method is not EO. It has been double checked with divisonal RA on this issue, and based on their feedback, gammer radiation is the only sterilzation method used for the product.
The description of UPN is different on the techinical file than that on the certificate. This is due to the different critieria used for the description. It seems that potential problems might generate from this issue.

yegao0427 commented 6 years ago

delayed.

yegao0427 commented 6 years ago

upn : Doc uses vessel diameter as product description techinical file uses unconstrained diameter and length as product description

yegao0427 commented 6 years ago

need to check with Lucy

yegao0427 commented 6 years ago

merge pdf