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Notified Body - Does anyone have experience using TUV Essex?

L

Larry Pool

#1
#1
Does anyone have experience using TUV Essex. We are a small medical device company looking for a responsive notified body who provides a timely review of Design Dossier CE Mark applications and change notices.

Referals are welcome.

Larry
 
QMS for Medical Device Companies
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I

IEGeek - 2006

#3
#3
I have never used TUV Essex, however TUV out of San Diego is great. I think that as a whole TUV is a great organization, and by letting them know up front in the quoting process you can help "push" them along to be as responsive as you need.

TUV out of San Diego was put under the gun with our latest CE project and completed it on time with no real hiccups to worry about.

Here is where I goofed up when I started the process.

"With the exception of some high-risk products, most products can be self- assessed by the manufacturer to meet the Essential Requirements. While CE Marking permits a product's access to the EU, it is not an approval certification or quality mark; nor is it intended to be a marketing tool. CE is a "Marking" that is only a declaration of the supplier's own responsibility. While enabling products to be placed on the European market, it only allows for the free movement of goods and permits the withdrawal of non-conforming products."
 
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