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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
Sean12

 
 
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!

Sean

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

 
 
Total Posts: 3,364
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
lsuelter

 
 
Total Posts: 3
Re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

Would you also be kind enough to contact me? Thank you.
  Post Number #4  
Old 12th September 2018, 11:49 AM
TheMightyWife

 
 
Total Posts: 10
Re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

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).
  Post Number #5  
Old 12th September 2018, 12:03 PM
lsuelter

 
 
Total Posts: 3
Re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

Quote:
In Reply to Parent Post by TheMightyWife View Post

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.
  Post Number #6  
Old 13th September 2018, 03:38 AM
TheMightyWife

 
 
Total Posts: 10
Re: CER (Clinical Evaluation Report) Writer Wanted - Nov 2017

That would be amazing! If you could ask...I have one week to write 2 CERs.
I'll private message you.
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