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MDR and Summary Technical Documentation Files
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MDR and Summary Technical Documentation Files
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  Post Number #9  
Old 30th May 2018, 11:29 AM
Rincewind

 
 
Total Posts: 5
Re: MDR and Summary Technical Documentation Files

Is it save to assume that this structure will become the new structure for the technical documentation expected by NBs and would it be a good idea to start structuring our technical documentation according to this document?

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  Post Number #10  
Old 22nd July 2018, 01:12 PM
coastalcg

 
 
Total Posts: 2
Re: MDR and Summary Technical Documentation Files

Hi All -

Has the EU posted their proposed Classification Matrices to describe the relevant elements of these IMDRF ToCs, as applied to 2017/745 MDR Technical Documentation requirements?

FDA has posted their Classification Matrices in November 2017.

Thanks!
  Post Number #11  
Old 27th July 2018, 04:02 AM
Gamula's Avatar
Gamula

 
 
Total Posts: 26
Re: MDR and Summary Technical Documentation Files

I am alone AND there are contradictions wihtin e. g. clinical investigation reports or standards to be used (China uses their and slightly different standards or old ISOs; Japan has their own UNIVERSE of standards; USA UDI differs from others like Turkey; etc.). I was all alone doing this, I am on the cutting edge of knowledge at the moment.
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