Clinical Evaluation Report - Consultant Recommendations

Dobby1979

Involved In Discussions
#1
Hi All.

I am looking to put a RFB together for writing a CER and probably a literature review. Does anyone have some recommendations for people that they have used previously? Have they submitted under the MDR?

We are a software company developing a Medical Device and looking to submit a Technical File for CE Marking Jan 2020.

Recommendations would be welcome.

Thanks.
 
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Marcelo

Inactive Registered Visitor
#2
This is not a recommendation, but my company's been performing clinical evaluations under the MDR for some time now.
 

Dobby1979

Involved In Discussions
#3
This is not a recommendation, but my company's been performing clinical evaluations under the MDR for some time now.
Hi Marcelo.

Sounds good. Could you drop me a private message (I cannot PM for some reason, it is being looked into) to discuss further and to get some quotes. I need to evaluate and put a proposal together for discussion in around two weeks. We will then look to instruct the vendor, around 3-4 weeks time I would guess.
 

Marcelo

Inactive Registered Visitor
#6
Who did you submit them to?
We do not submit them, our clients do. But they have not submitted them to anyone yet as they are not being evaluated under the MDR yet (although the clinical evaluations we did were created to comply with the revised MDR requirements).
 
#8
Hi All,

I am also looking for a consultant to create a Clinical Evaluation Report for a Medical Device Disinfectant (Class IIa-EU MDD/MDR).

I am having difficulty using the PM function, if interested can you PM me.

Thanks,
 
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