ISO/TR 14969:2004(E)© ISO 2004 TECHNICAL REPORT ISO/TR14969First edition2004-10-15Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003 Dispositifs médicaux — Systèmes de gestion de qualité — Lignes directrices pour l'application de l'ISO 13485:...
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003doi:ISO/TR 14969:2004ISO/TR 14969:2004提供了ISO 13485中质量管理体系要求的应用指南.它不会增加或改变ISO 13485的要求.它不包括用作监管检查或认证评估活动基础的要求.\n本指南可用于更好地理解ISO 13485的要求...
国际标准分类中,guidance on the application of iso13485涉及到。在中国标准分类中,guidance on the application of iso13485涉及到。VDE - VDE Verlag GmbH@ Berlin@ Germany,关于guidance on the application of iso13485的标准VDE V 0674-276-2016 Guidance on the measurement of hydrophobicity of insulator ...
FDAstafforOfficeresponsibleforthisguidanceaslistedonthetitlepage. I.Introduction Off-the-shelf(OTS)Softwareiscommonlybeingconsideredforincorporationintomedical devicesastheuseofgeneral-purposecomputerhardwarebecomesmoreprevalent.Theuseof OTSSoftwareinamedicaldeviceallowsthemanufacturertoconcentrateontheapplication ...
发布时间:2023-6-30 | 云展网画册制作 产品说明书 其他 ghtf-sg3-n17-guidance-on-quality-management-system-081211 GHTF/SG3/N17:2008 FINAL DOCUMENT Title: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers Authoring Group: GHTF...
摘要: 交叉引用:IEC 62304:2006ISO 14971:2007ISO 13485IEC 60812IEC 61025IEC 61882IEC 62366IEC 80001-1购买本文件时提供的所有现行修订版均包含在购买本文件中.发布日期: 2009-09-23 收藏 引用 批量引用 报错 分享 全部来源 求助全文 掌桥科研 研究点推荐 Medical device software ISO 14971 ...
On the other hand, in the US, the biotechnologyindustry,ratherthanFDA,isresponsibleformonitoring the labelling of GM food. legco.gov.hk legco.gov.hk 在美國,生物科技業而非食物及 藥 物管理局負責自行監察基因改造食物的標籤工作。 legco.gov.hk ...
ISO 26000 Guidance on Social Responsibility: Demonstrate your commitment to sustainable development and community support. ISO 26000 can help you address everything from working practices to environmental policies, sustainable development and the communi
This program was established to encourage innovators to conduct testing and confirm any impact of new plastic designs and components on recycling, and to help companies seeking sustainable packaging to find recyclable solutions. In order to achieve the vision of green, sustainable development, Majesty...
Some reasons for revalidation Change in process that may affect quality or validation status Negative trend in quality indicators Change in the product design that affects the process Process is moved within facility or transferred from one facility to another Change in the application of the process...