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Watchcat

Watchcat

Trusted Information Resource
#4
#4
A couple of questions for you:

1. Is the company currently a client of an MDR-designated NB? An NB that is seeking MDR designation? Or are is it going to have to find one?

2. Are you sure it needs help with the transition, or might it be at step 0, which is the step where you figure whether it will make any business sense to keep the product on the EU market post-MDR?
 
S

SMBIZZQA

Starting to get Involved
#5
#5
1. Yes, we currently have an NB, and already have certification and CE.
2. We definitely need to transition, however I currently don't have the resources to do all the necessary steps. Basically need someone to come in and review what we currently have in our tech files and do a gap analysis for us. I am a one party QA department.
 
Watchcat

Watchcat

Trusted Information Resource
#6
#6
That's good!

That was going to be my next question...what kind of assistance do you need. I'm going to contact you via PM, but I asked these questions here on the thread because I think anyone who might be available to help you will find it helpfu.
 
Watchcat

Watchcat

Trusted Information Resource
#7
#7
Oh! Something else I think others will find helpful to know:

What is the basis for the organization and contents of your current technical file? NB-MED 2.5.1? STED?
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#8
#8
If I may recommend myself, I do... I'd be glad to help.
I don't mind travelling, but I'm not sure it would be cost-effective in this case... I'm based in Australia. However, I'm very confident (based on experience) that the gap analysis and the vast majority of any required gap filling can be done remotely.
Please send me a PM if interested.
Cheers,
Ronen.
 
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