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matériovigilance

English translation: medical devices vigilance

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13:23 Apr 27, 2001
French to English translations [PRO]
Medical
French term or phrase: matériovigilance
Contrôle matériovigilance
La matériovigilance a pour objet la surveillance des incidents ou des risques d’incidents résultant de l’utilisation des dispositifs médicaux.
Paul Sadur
Local time: 21:30
English translation:medical devices vigilance
Explanation:
All credit to second answerer!

1 - http://www.sante.gouv.fr/htm/pointsur/materio/

La matériovigilance a pour objet la surveillance des incidents pouvant survenir lors de l'utilisation du matériel médical.
Elle vise un champ d'application spécifique qui complète depuis peu d'autres modalités de la sécurité sanitaire.
Quiconque peut avoir à signaler un incident, bien que la matériovigilance concerne surtout les professionnels de santé. Il est donc nécessaire de bien en connaître les règles.
La matériovigilance trouve son origine dans les directives européennes relatives à la mise sur le marché de matériel médical. La transposition en droit national de ces directives, définit l'organisation retenue par la France pour son système de matériovigilance.

Professionnels de la santé :
Vous pouvez directement consulter :
les recommandations de signalement
les mesures de sécurité sanitaires prises par le ministère depuis 1995
les membres de la commission nationale de matériovigilance désignés par le ministère

2 - http://www.materiovigilance.com/ (bi-lingual site : FR/EN - GB & US)
"The medical devices vigilance site"
Welcome to HosmaT
The medical devices vigilance site

"The purpose of medical device vigilance is to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incidents being repeated in different places at different times. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent such repetitions, or to alleviate the consequences of such incidents" [MEDDEV 3/93-rev2].
Medical device vigilance therefore includes adverse incidents notification as well as recording, evaluation and exploitation of the information reported in order to improve prevention.

France : Incidents / Alerts reported and notified since 1998
Add your name on our list and receive up-to-date information regarding publications (circular letters, decrees…)
France : The cerfa notification form
EEC : GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EEC : Demarcation between MEDICAL DEVICES DIRECTIVES and
MEDICINAL PRODUCTS DIRECTIVES




Selected response from:

Nikki Scott-Despaigne
Local time: 04:30
Grading comment
This is great! I also have "pharmacovigilance" and "hémovigilance". I may use this as the model.
Thanks.

4 KudoZ points were awarded for this answer

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Summary of answers provided
namedical devices vigilance
Nikki Scott-Despaigne
naMedical devices vigilance
jmleger
naappliance check,, control
Guy Bray


  

Answers


9 mins
appliance check,, control


Explanation:
the matério is explained by dispositifs below

Guy Bray
United States
Local time: 19:30
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 819
Login to enter a peer comment (or grade)

20 mins
Medical devices vigilance


Explanation:
http://srd.yahoo.com/goo/matriovigilance/2/*http://www.materi...

jmleger
Local time: 21:30
Native speaker of: Native in FrenchFrench
PRO pts in pair: 696
Login to enter a peer comment (or grade)

1 hr
medical devices vigilance


Explanation:
All credit to second answerer!

1 - http://www.sante.gouv.fr/htm/pointsur/materio/

La matériovigilance a pour objet la surveillance des incidents pouvant survenir lors de l'utilisation du matériel médical.
Elle vise un champ d'application spécifique qui complète depuis peu d'autres modalités de la sécurité sanitaire.
Quiconque peut avoir à signaler un incident, bien que la matériovigilance concerne surtout les professionnels de santé. Il est donc nécessaire de bien en connaître les règles.
La matériovigilance trouve son origine dans les directives européennes relatives à la mise sur le marché de matériel médical. La transposition en droit national de ces directives, définit l'organisation retenue par la France pour son système de matériovigilance.

Professionnels de la santé :
Vous pouvez directement consulter :
les recommandations de signalement
les mesures de sécurité sanitaires prises par le ministère depuis 1995
les membres de la commission nationale de matériovigilance désignés par le ministère

2 - http://www.materiovigilance.com/ (bi-lingual site : FR/EN - GB & US)
"The medical devices vigilance site"
Welcome to HosmaT
The medical devices vigilance site

"The purpose of medical device vigilance is to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incidents being repeated in different places at different times. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information which could be used to prevent such repetitions, or to alleviate the consequences of such incidents" [MEDDEV 3/93-rev2].
Medical device vigilance therefore includes adverse incidents notification as well as recording, evaluation and exploitation of the information reported in order to improve prevention.

France : Incidents / Alerts reported and notified since 1998
Add your name on our list and receive up-to-date information regarding publications (circular letters, decrees…)
France : The cerfa notification form
EEC : GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EEC : Demarcation between MEDICAL DEVICES DIRECTIVES and
MEDICINAL PRODUCTS DIRECTIVES







    Reference: http://www.sante.gouv.fr/htm/pointsur/materio
    Reference: http://www.materiovigilance.com
Nikki Scott-Despaigne
Local time: 04:30
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 4431
Grading comment
This is great! I also have "pharmacovigilance" and "hémovigilance". I may use this as the model.
Thanks.
Login to enter a peer comment (or grade)




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