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CER (Clinical Evaluation Report) Writer Wanted - Nov 2017
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CER (Clinical Evaluation Report) Writer Wanted - Nov 2017
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  Post Number #1  
Old 31st October 2017, 03:09 PM

Total Posts: 1
Read This! CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

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!


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  Post Number #2  
Old 31st October 2017, 03:51 PM
Marcelo Antunes's Avatar
Marcelo Antunes

Total Posts: 3,283
re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

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.
  Post Number #3  
Old 28th November 2017, 12:19 PM

Total Posts: 2
Re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

Would you also be kind enough to contact me? Thank you.

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