Décision du 20 mars 2014 portant renouvellement de l'agrément d'un organisme chargé du contrôle de qualité externe de certaines installations de radiodiagnostic
Jurisdiction | France |
ELI | https://www.legifrance.gouv.fr/eli/decision/2014/3/20/AFSM1400052S/jo/texte |
Record Number | JORFTEXT000028891185 |
Date de publication | 04 mai 2014 |
Publication au Gazette officiel | JORF n°0104 du 4 mai 2014 |
Court | Ministère des affaires sociales et de la santé |
Enactment Date | 20 mars 2014 |
Le directeur général de l'Agence nationale de sécurité du médicament et des produits de santé,
Vu le code de la santé publique, notamment ses articles L. 5212-1 et R. 5212-25 à R. 5212-35 ;
Vu l'arrêté du 3 mars 2003 fixant les listes des dispositifs médicaux soumis à l'obligation de maintenance et au contrôle de qualité mentionnés aux articles L. 5212-1 et R. 5212-26 du code de la santé publique ;
Vu l'arrêté du 20 novembre 2007 relatif à l'agrément des organismes de contrôle de qualité externe des dispositifs médicaux prévu à l'article R. 5212-29 du code de la santé publique ;
Vu la décision du 24 septembre 2007 fixant les modalités du contrôle de qualité de certaines installations de radiodiagnostic ;
Vu la décision d'agrément de la société AM'TECH Médical pour le contrôle de qualité externe de certaines installations de radiodiagnostic du 23 mars 2009 ;
Vu l'accréditation n° 3-0636 rév. 6 délivrée à la société AM'TECH Médical par le COFRAC au titre de son programme d'accréditation INS REF 14 pour le contrôle de qualité externe des dispositifs médicaux, prenant effet à compter du 1er mars 2013 ;
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