![ZEISS Medical Industrial Solutions Qualité et conformité]({"xsmall":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.100.33.file/zeiss_ncs_web_temp_1920x640px_01.jpg","small":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.360.120.file/zeiss_ncs_web_temp_1920x640px_01.jpg","medium":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.768.256.file/zeiss_ncs_web_temp_1920x640px_01.jpg","large":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.1024.341.file/zeiss_ncs_web_temp_1920x640px_01.jpg","xlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.1280.427.file/zeiss_ncs_web_temp_1920x640px_01.jpg","xxlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original.image_file.1440.480.file/zeiss_ncs_web_temp_1920x640px_01.jpg","max":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_ncs_web_temp_1920x640px_01.jpg/_jcr_content/renditions/original./zeiss_ncs_web_temp_1920x640px_01.jpg"} "ZEISS Medical Industrial Solutions Qualité et conformité")
Qualité et conformité
La sécurité et la santé des patients sont au cœur de la technologie médicale. C'est pourquoi l'industrie des technologies médicales est l'une des industries les plus réglementées. ZEISS comprend les exigences et les défis qui en découlent pour les entreprises.
Les entreprises internationales doivent se conformer aux réglementations de diverses autorités. En Europe, ces règles sont définies dans différentes directives CE (règlements et directives des Communautés européennes) et résumées dans le Règlement relatif aux dispositifs médicaux (MDR). Aux États-Unis, la Food and Drug Administration (FDA) est l'organisme de réglementation compétent. Des directives distinctes sont par ailleurs en vigueur en Chine, au Canada, en Amérique du Sud et dans d'autres pays.
Franchissez les obstacles réglementaires de l'industrie médicale
![]({"xsmall":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.100.33.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","small":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.360.120.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","medium":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.768.256.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","large":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.1024.341.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","xlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.1280.427.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","xxlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.1440.480.150,456,1877,1032.file/regulatorien_header_1920x960.jpg","max":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/regulatorien_header_1920x960.jpg/_jcr_content/renditions/original.image_file.1727.576.150,456,1877,1032.file/regulatorien_header_1920x960.jpg"})
![Fonctionnalités clés de la boîte à outils ZEISS ZEN core GxP]({"xsmall":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original.image_file.100.75.file/zeiss_software_implantat_x-ray.jpg","small":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original.image_file.360.270.file/zeiss_software_implantat_x-ray.jpg","medium":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original.image_file.768.576.file/zeiss_software_implantat_x-ray.jpg","large":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original./zeiss_software_implantat_x-ray.jpg","xlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original./zeiss_software_implantat_x-ray.jpg","xxlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original./zeiss_software_implantat_x-ray.jpg","max":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original./zeiss_software_implantat_x-ray.jpg"} "Solutions logicielles ZEISS pour la microscopie")
La solution logicielle ZEISS pour la microscopie comprend :
- la conformité aux exigences des normes DIN EN ISO 13485 et FDA 21 CFR Partie 11 ;
- la gestion sécurisée des utilisateurs ;
- l'intégration d'une piste d'audit et de la gestion des versions ;
- la création automatique de certificats et de certificats d'essai pour les fabricants ;
- la validation continue ;
- le versionnage des documents et la protection contre les modifications ;
- des concepts d'autorisation détaillés, dont les signatures électroniques ;
- la reprise après sinistre ;
- des indicateurs de performance en ligne à l'échelle de l'entreprise
En savoir plus sur la réglementation dans l'industrie médicale
![Flux de tâches sécurisés et traçables en microscopie]({"xsmall":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.100.56.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","small":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.360.203.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","medium":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.768.432.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","large":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.900.506.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","xlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.900.506.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","xxlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.900.506.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png","max":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/zeiss_video-image_secure-and-traceable-microscopy-workflows.png/_jcr_content/renditions/original.image_file.900.506.4,0,904,506.file/zeiss_video-image_secure-and-traceable-microscopy-workflows.png"} "Flux de tâches sécurisés et traçables en microscopie")
![#measuringhero | Épisode 71 : Article 21 de la FDA : Allez plus loin]({"xsmall":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.100.56.28,0,881,480.file/measuringhero_episode77.png","small":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.360.203.28,0,881,480.file/measuringhero_episode77.png","medium":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.768.432.28,0,881,480.file/measuringhero_episode77.png","large":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.853.480.28,0,881,480.file/measuringhero_episode77.png","xlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.853.480.28,0,881,480.file/measuringhero_episode77.png","xxlarge":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.853.480.28,0,881,480.file/measuringhero_episode77.png","max":"https://www.zeiss.fr/content/dam/iqs/r/industries/medical/regulatory/measuringhero_episode77.png/_jcr_content/renditions/original.image_file.853.480.28,0,881,480.file/measuringhero_episode77.png"} "#measuringhero | Épisode 71 : Article 21 de la FDA : Allez plus loin")
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