Clinical Evaluation Report for a Delivery System

E

eileenr

#1
Hello Everyone,
I am definitely a quality person however, I have been asked to complete a CER for a class 2 a delivery system. The delivery system has been approved for a CE mark for two other companies already. I am currently trying to do the literature search review and the key terms I am using are too broad for this particular syringe/mixer delivery device. As this product has already been approved is there someplace that I can see the CER that was produced in order that they received the CE mark. I have never done this before so I apologise if this is a silly question.
Thank you so much
E
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Hello Everyone,
I am definitely a quality person however, I have been asked to complete a CER for a class 2 a delivery system. The delivery system has been approved for a CE mark for two other companies already. I am currently trying to do the literature search review and the key terms I am using are too broad for this particular syringe/mixer delivery device. As this product has already been approved is there someplace that I can see the CER that was produced in order that they received the CE mark. I have never done this before so I apologise if this is a silly question.
Thank you so much
E
Hi,

Other than searching the web for related white papers I can't really think of any way you could get such reference. Clinical evaluation reports are typically internal proprietary documents. Usually their preparation involves significant resources, so I doubt any commercial company would easily share them, especially if we're talking about a small niche product.

Cheers,
Ronen.
 
E

eileenr

#3
Good Morning Ronan,
I thought that it was a long shot alright, confidentiality being an issue also. I appreciate the feedback so much. I will continue searching, I do not believe this will be too complicated, the med dev is very clear.
:D
 
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