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View Full Version : Looking for an accredited FDA MED-DEV 3rd Party Auditor


TJG954
10th September 2007, 02:36 PM
........somewhere in Florida (south Florida preferred). Any recommendations/

Thanks, Ted

Aaron Lupo
11th September 2007, 08:03 AM
........somewhere in Florida (south Florida preferred). Any recommendations/

Thanks, Ted

Are you looking for a Notified Body or a consultant?

Al Rosen
11th September 2007, 08:51 AM
Try:
http://www.rabqsa.com/search.html

TJG954
11th September 2007, 09:23 AM
I should have explained.....

A while back, one of the real giant corporations had a subsidiary medical device company blow off the FDA. It ended up costing the parent company millions of dollars (and it's not over yet).
:nopity:

Keeping this in mind, our company has an opportunity to hook up with another giant who wants to be sure we're doing things the right way. That's why we're looking for a total outsider to evaluate our system and operations.
:read:

It isn't a binding audit, just a qualified opinion as to our condition.
:cfingers:

mlabardi
11th September 2007, 12:01 PM
There are two consulting firms that I have had success with. Both firms are run by ex-FDA consumer safety officers. I was very impressed with their work. They are not based in south florida but they may have some constituents who are located closer to you. They do a lot of traveling so I am pretty sure they would go to you if you were interested.

EHKrohl Consulting
fdacompliance.com

Bioassist Consulting Services
bioassist.com

Good luck!:)