![ZEISS Tıp Sektörü Çözümleri Kalite ve Uyumluluk]({"xsmall":"https://www.zeiss.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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 Tıp Sektörü Çözümleri Kalite ve Uyumluluk")
ZEISS Tıp Sektörü Çözümleri
Kalite ve Uyumluluk
Tıbbi teknolojinin odak noktasında hastaların güvenliği ve sağlığı yer almaktadır. Bu nedenle, tıbbi teknoloji sektörü yoğun şekilde düzenlemeye tabi sektörlerden biridir. ZEISS, gereksinimlerin ve bunun sonucunda şirketlerin karşılaştığı zorlukların farkındadır.
Küresel şirketlerin çeşitli yetkili makamların düzenleme gereksinimlerini yerine getirmesi gerekmektedir. Örneğin Avrupa'da bu kurallar farklı AT direktiflerinde (Avrupa Toplulukları yönetmelikleri ve kılavuzları) tanımlanmakta ve MDR'de (Tıbbi Cihaz Yönetmeliği) özetlenmektedir. ABD'de Gıda ve İlaç İdaresi (FDA) ilgili düzenleyici kurumdur. Çin, Kanada, Güney Amerika vb. başka bölgelerde de ayrı kılavuzlar uygulanmaktadır.
Düzenleme odaklı bir sektörde engellerin aşılması
![]({"xsmall":"https://www.zeiss.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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"})
![ZEISS ZEN core GxP Toolkit'in temel işlevleri]({"xsmall":"https://www.zeiss.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/content/dam/iqs/r/industries/medical/regulatory/zeiss_software_implantat_x-ray.jpg/_jcr_content/renditions/original./zeiss_software_implantat_x-ray.jpg"} "Mikroskopi için ZEISS Yazılım Çözümleri")
Mikroskopi için ZEISS yazılım çözümü şunları içerir:
- DIN EN ISO 13485 ve FDA 21 CFR Bölüm 11 gerekliliklerine uygunluk
- Güvenli kullanıcı yönetimi
- Denetim izi ve serbest bırakma yönetiminin entegrasyonu
- Sertifikaların ve üretici test sertifikalarının otomatik olarak oluşturulması
- Sürekli doğrulama
- Belgelerin sürümlendirilmesi ve değişikliklere karşı korunması
- Elektronik imzalar dahil detaylı yetkilendirme kavramları
- Olağanüstü durum kurtarma
- Şirket çapında çevrimiçi performans göstergeleri
![Güvenli ve İzlenebilir Mikroskopi İş Akışları]({"xsmall":"https://www.zeiss.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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"} "Güvenli ve İzlenebilir Mikroskopi İş Akışları")
![#measuringhero | Bölüm 71: FDA Başlık 21 Deep Dive]({"xsmall":"https://www.zeiss.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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.com.tr/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 | Bölüm 71: FDA Başlık 21 Deep Dive")