CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

#1
Hello All,

First post on here but not the first time I've used this forum as helpful resource.

Our company is in the process of getting ISO/CE certification (ISO 13485: 2016) and we've run into the Clinical Evaluation Report requirement; of which we have never done. Our NB suggested the literature route given the lack of a prior CER.

Our products are medical devices (not new) and are all class IIa. In years past, we haven't needed the CER for the Technical Documents but the new directive requires this as most probably know.

In summary, the CER is beyond the capacity of anyone at our company especially with the requirement of attaching CV's of the author(s). Therefore, we are looking for a qualified individual with experience who can take this on for us.

I can provide additional information to anyone who might be interested.

Thanks in advance!

Sean
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#2
Hello Sean, my team and me have been writing succeful CERs for CE marking following the most recent MEDDEV for some time now. I will contact you by PM with contact info.
 

TheMightyWife

Starting to get Involved
#4
Hi Marcelo. Are you able to contact me as well in regards to CER for well established class IIa medical devices (5 different medical device files)? It's really urgent and I'm hoping you would be able to help (CER based on clinical literature research in dental field).
 
#5
Hi Marcelo. Are you able to contact me as well in regards to CER for well established class IIa medical devices (5 different medical device files)? It's really urgent and I'm hoping you would be able to help (CER based on clinical literature research in dental field).
I ended up writing the CER myself following the format example contained in MEDDEV 2.7/1 r4 beginning on page 50. It was accepted by the N.B. without follow up. I could possibly send a sanitized version if my management agrees.
 
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