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Does medical devices standard terminology exist?
ناشر الموضوع: Patrizia Ferrara (X)
Patrizia Ferrara (X)
Patrizia Ferrara (X)  Identity Verified
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Mar 1, 2011

Hello every body!
I was wondering if it exists a standard terminology for IVD IFU (and other IVD related documents).

In exemple:
In the field of Pharmacology, EMEA produced some "standard templates" in different European lang... See more
Hello every body!
I was wondering if it exists a standard terminology for IVD IFU (and other IVD related documents).

In exemple:
In the field of Pharmacology, EMEA produced some "standard templates" in different European languages for Summary of Product Characteristics (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac0580022c59&jsenabled=true).
Is there any equivalent for IVD? and/or for other medical devices?
does anything equivalent to MedDra dictionary (www.meddramsso.com) exist for medical devices?

Thank you for your attention!

Patti ▲ Collapse
 
Muharrem Taner
Muharrem Taner
Local time: 07:35
Impossible! Mar 1, 2011

Ir is a cut-throat market, and many items are named in different codes, while they have the same features and functions.
hth
 
SJLD
SJLD

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EU guidelines Mar 1, 2011

Not exactly templates - but you might find something of use among these documents:

http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm
 
Lionel_M (X)
Lionel_M (X)
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Guidelines for Italy Mar 1, 2011

Hy Patrizia, I see your target language is Italian.
This may help you for our language:
http://www.salute.gov.it/dispositivi/paginainterna.jsp?id=36&menu=sperimentazione

Kind regards,
Lionel
 
Patrizia Ferrara (X)
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Many thanks to everybody! Mar 4, 2011

I am now studying these references documents in Italian, (the second is the Italian d.lgs for 98/79CE).
http://www.salute.gov.it/imgs/C_17_pubblicazioni_1238_allegato.pdf
http://www.salute.gov.it/imgs/C_17_normativa_544_allegato.pdf
... See more
I am now studying these references documents in Italian, (the second is the Italian d.lgs for 98/79CE).
http://www.salute.gov.it/imgs/C_17_pubblicazioni_1238_allegato.pdf
http://www.salute.gov.it/imgs/C_17_normativa_544_allegato.pdf
Thanks again!!!
Patrizia ▲ Collapse
 


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Does medical devices standard terminology exist?







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