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Laminaria - Biocompatibility Study?

Posted 15th August 2014 at 10:31 AM by sherley13

Laminaria it is Ocean Kelp dried and cut to 60mm size and classified by mm thickness size. It is a natural product of vegetable origin. Being a Class 2 Device by FDA and by Medical Device Directives of the European Union, we are required to study the...
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Resterilization - Disposable devices

Posted 7th August 2014 at 01:30 PM by sherley13
Updated 7th August 2014 at 01:49 PM by sherley13

Dear All,

The Disposable devices packed in Tyvek pouch and sterilized by Ethylene Oxide and this device is sterilized by original manufacturer. Can distributor do Re-sterilization of this product again?.

(Note : The product...
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FDA facility Registration

Posted 23rd July 2014 at 10:55 AM by sherley13
Some Related Topic Tags impartiality risk assessment

Dear Sir,

This is with regards to FDA facility registration the question is : X company is located in Asian continent and it is a trading company and this X company wants to register their facility in USFDA. The X company is buying...
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7 WASTES 七大浪费

Posted 17th June 2014 at 09:02 PM by lokeky1

1.Overproduction 生产过剩的浪费
2.Waiting 等待的浪费
3.Transportation 搬运的浪费
4.Over processing 过度处理的浪费
6.Motion 动作的浪费
7.Defect 报废
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Posted 26th May 2014 at 11:24 AM by bobdoering (Bob Doering)
Updated 3rd June 2016 at 03:20 PM by bobdoering

Here is a handy index for the information in my blog! (Be sure to click Continue reading... below to see the whole page!)


The CORRECT steps to implement an SPC chart

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Stop X-bar/R Madness!!
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