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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
5.Inventory库存的浪费
6.Motion 动作的浪费
7.Defect 报废
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INDEX TO CONTENT ON BOB DOERING'S BLOG!

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!)

SPC GENERAL

The CORRECT steps to implement an SPC chart


SPC FOR PRECISION MACHINING...
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Stop X-bar/R Madness!!
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