How to choose an EU Authorized Representative for a Medical Device

D

Dollymixture

#1
Can someone help me please.
I am doing some regulatory work for a client who is a manufacturer based in US who intends to market a Class IIa medical device in the EU this year, with a class I device due in 2016. I am trying to identify a suitable EU authorized rep. Can anyone give me some advice on selecting an EU Rep. A google search has thrown up many options, but I would welcome any suggestions or recommendations. Can anyone give me a ballpark on what approximately this should cost per year.
thanks in advance
 
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yodon

Staff member
Super Moderator
#2
I have pretty limited experience here but I've worked with Emergo as the AR for a couple of clients and have been satisfied with them (I have no affiliation with them). I've never done a cost comparison.
 

somashekar

Staff member
Super Moderator
#3
To compare and take a decision, also look at MDSS <MDSS>...
You can quote my name to MDSS.
.
..
...

<<< I am not associated with MDSS in any business except being his customer since many years >>>
 
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