Is getting a UDI Consultant a good idea?

Java23

Involved In Discussions
Hi - I am the lead for the UDI project. We need to be compliant by September 2016 for Class II devices (reprocessed/reusable).

I am doing my best to "teach myself" and have been thinking it would be best to use a consultant.

Has anyone used a consultant and if so, any ideas or suggestions?

I have looked online and am not finding a lot of options.

Thanks in Advance.:thanks:
 

yodon

Leader
Super Moderator
Re: UDI Consultants

I am not endorsing and I have no affiliation with them - I only sat through a webinar they provided. They seemed to have a reasonable understanding of the situation. I hope that's enough caveats. :) With those, you might try Reed Tech:

Haley Lentz
O: +1-215-441-6438 C: +1-215-756-7216
www.ReedTech.com - [email protected]
 

Java23

Involved In Discussions
:thanks:I had considered them for the submission to the GUDID but wasn't sure about the consulting portion. Thanks much :)
 

Ronen E

Problem Solver
Moderator
Hi - I am the lead for the UDI project. We need to be compliant by September 2016 for Class II devices (reprocessed/reusable).

I am doing my best to "teach myself" and have been thinking it would be best to use a consultant.

Has anyone used a consultant and if so, any ideas or suggestions?

I have looked online and am not finding a lot of options.

Thanks in Advance.:thanks:

I am available if you're interested. Please send a PM.

Cheers,
Ronen.
 
J

Julie O

I normally think of a consultant as someone who has extensive experience in a particular area. The problem with UDI is that so far no one has extensive experience with it, because it's new. This is probably why you are not finding a lot of options.

Perhaps a more useful question under these circumstances might be "what type of experience should a UDI consultant have? You may find that, at this point in the history of UDI, you are as qualified to be a UDI consultant as anyone. If not, then you will at least know what you are looking for in a UDI consultant.

Also, are you aware that you posted this in the subforum for "Other Medical Device Regulations Worldwide," rather than "Other US Medical Device Regulations"? Since UDI is a US medical device regulation, I think you will find more UDI folks in the other sub-forum, where there has been quite a lot of chatter about the UDI.
 
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