Example of a Risk Assessement File for Medical Device

#1
Hi There,

Where can I find the example of complete file of risk assessment (regarding to ISO 14971).
My company produce the hearing aids.

Thank you in advance for all advice.

:thanx:
 
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Peter West

#2
Hi Mikijang

I know you probably looked already but in the Post Attachments List there are a couple of references to risk assessment reports etc. Not sure exactly what you are looking for in reference to 'file' but hope that helps.

Thanks

Peter
 
Last edited by a moderator:

Emma2010

Starting to get Involved
#4
Dear Peter,

Can you please share that link again? It could not be found anymore.
Look forward to hearing from you soon.
Thank you very much!

Yours sincerely,
Emma
 
Last edited by a moderator:

Rincewind

Involved In Discussions
#5
Dear Peter,

Can you please share that link again? It could not be found anymore.
Look forward to hearing from you soon.
Thank you very much!

Yours sincerely,
Emma
Hello Emma,

this was 8 years ago but I think Peter simply performed a search in the attachment list of the forum for the term "14971".

It is slightly different since the forum move:
Attachment Listing

Best Regards,
Rince
 

Emma2010

Starting to get Involved
#6
Hello Emma,

this was 8 years ago but I think Peter simply performed a search in the attachment list of the forum for the term "14971".

It is slightly different since the forum move:
Attachment Listing

Best Regards,
Rince
Dear Rincel,
I apologize for my failure to realize the date.
I appreciate it very much for your prompt reply!
Wish you have a lovely weekend!

Yours sincerely,
Emma
 
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