恭賀：獲得ISO 13485:2003與ISO 9001:2000 國際品質認證
恭賀！本公司獲得ISO 13485:2003與ISO 9001:2000 國際品質認證
日祥生命科學股份有限公司於2011年正式將業務範圍從「臨床科學服務」領域，拓展至「新型癌症檢測試劑開發」的創新型生技醫藥領域。
為使產品開發及生產製造符合國際化品質標準，日祥積極完善及程序化各項作業流程，並於2012年1月6日正式獲得UKAS與SGS雙認證的醫療器材製造業品質標準ISO 13485:2003「基因檢測試劑套組開發與生產製造」與臨床科學/醫療器材開發的ISO 9001:2000「基因檢測試劑套組開發與生產製造暨藥物及臨床研究服務」。
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iStat Biomedical announces the receipt of ISO13485:2003 and ISO 9001:2000 certification |
iStat Biomedical Co. Ltd., announces to be awarded of the two quality system, ISO 13485:2003 and ISO 9001:2000 certification, from SGS. The item "Design and manufacture of gene detection kits" is accredited under ISO 13485:2003 for manufacturing of medical device, whereas "Design and manufacture of gene detection kits & providing medical and clinical research service" is accredited under ISO 9001:2000 for providing medical device clinical research services.
About iStat Biomedical
iStat Biomedical is a Taiwan-based biotechnology company specialized in the development and manufacturing of gene methylation assay IVD products for the early detection of cancers. iStat Biomedical develops innovative products that are primarily used in the clinical laboratories, and provides physicians with alternative solutions for clinical managements. iStat Biomedical also provides services for gene methylation detection and IVD contract manufacturing.
iStat Biomedical Co., Ltd contact:
+886-2-26963518
恭賀！本公司獲得ISO 13485:2003與ISO 9001:2000 國際品質認證
日祥生命科學股份有限公司於2011年正式將業務範圍從「臨床科學服務」領域，拓展至「新型癌症檢測試劑開發」的創新型生技醫藥領域。
為使產品開發及生產製造符合國際化品質標準，日祥積極完善及程序化各項作業流程，並於2012年1月6日正式獲得UKAS與SGS雙認證的醫療器材製造業品質標準ISO 13485:2003「基因檢測試劑套組開發與生產製造」與臨床科學/醫療器材開發的ISO 9001:2000「基因檢測試劑套組開發與生產製造暨藥物及臨床研究服務」。
|
|
iStat Biomedical announces the receipt of ISO13485:2003 and ISO 9001:2000 certification |
iStat Biomedical Co. Ltd., announces to be awarded of the two quality system, ISO 13485:2003 and ISO 9001:2000 certification, from SGS. The item "Design and manufacture of gene detection kits" is accredited under ISO 13485:2003 for manufacturing of medical device, whereas "Design and manufacture of gene detection kits & providing medical and clinical research service" is accredited under ISO 9001:2000 for providing medical device clinical research services.
About iStat Biomedical
iStat Biomedical is a Taiwan-based biotechnology company specialized in the development and manufacturing of gene methylation assay IVD products for the early detection of cancers. iStat Biomedical develops innovative products that are primarily used in the clinical laboratories, and provides physicians with alternative solutions for clinical managements. iStat Biomedical also provides services for gene methylation detection and IVD contract manufacturing.
iStat Biomedical Co., Ltd contact:
+886-2-26963518