The article discusses a European directive passed by the European Parliament that requires the clear labeling of medical devices using chemicals known as phthalates. Di(2-ethylhexyl) phthalate (DEHP) is a compound used to soften vinyl plastic found in medical devices such as intravenous bags and ...
Siemens' integrated Labeling & UDI system offers the flexibility to create and regulate labeling data across the lifetime. In addition, we have created a dedicated medical device labeling mechanism to satisfy the industry's particular regulatory needs, notably with regard to the design and production...
With the increasing complexity and risk in the medical device industry, the need for end-to-end labeling is critical. The ability to integrate labeling should be a core process for medical device manufacturers. The demands that organizations are battling can pose both a gr...
Siemens Labeling and UDI solution is a cloud, SaaS Teamcenter X industry solutionPLM for Medical Devicesand part of theDesign Excellence digital thread portfoliothat helps medical device manufacturers create robust and innovative medical device designs quicker with no compromise on quality. For more info...
TEKLYNX CENTRAL CFR for Label Management Pull label elements from a centralized database for UDI-compliant labels Automate labeling process with central management to ensure process enforcement and additional control LEARN MOREWhy TEKLYNX is the Best Labeling Software for Medical Devices READ MORE About...
Medical device labeling applications Easily design and print barcode labels that are compliant with medical device industry standards. UDI compliant labels Design labels of all sizes HIBC andGS1Databar barcode creation Accurate labels for medical devices ...
Medical devices are held to a high standard and are regulated by stringent governmental and independent standards. Medical device labeling, likewise, is a strictly regulated process. Resource Label Group customizes design, construction and manufacturing process solutions for medical device labels that abid...
The medical device labeling and packaging must be scientific, authentic, intact, accurate and consistent with the properties of the product. For imported medical devices, the device labeling and packaging shall be in Chinese, the foreign language can be used if necessary.Services...
Many of the requirements for IEC 60601-1 also support compliance to various national regulations for medical devices. However, defining a medical device's target market prior to deciding the marking and labeling program saves medical manufacturers both time and money. Once the target market is estab...
由美国食品和药物管理局(FDA)发布的关于Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (PDF Only)(标签-医疗器械监管要求(FDA 89-4203)(仅PDF)),来源于药智数据政策法规数据库。