技术
- 网络安全和隐私 - 安全合规
- 平台即服务 (PaaS) - 设备管理平台
适用行业
- 电子产品
- 医疗保健和医院
适用功能
- 维护
- 产品研发
用例
- 库存管理
- 时间敏感网络
服务
- 系统集成
- 测试与认证
关于客户
MediBeacon 是一家医疗技术公司,专注于荧光示踪剂和透皮测量的进步。该公司拥有多种处于临床开发不同阶段的组合产品(包括医疗器械和诊断剂)。 MediBeacon® 透皮 GFR 测量系统 (TGFR) 用于测量肾功能受损或正常患者的肾小球滤过率 (GFR)。该公司致力于将变革性技术引入医疗实践,目标是提供对患者护理质量和成本产生深远积极影响的产品。
挑战
MediBeacon 是一家医疗技术公司,在将 III 类设备推向市场时,在管理文档和准备纸质质量管理系统 (QMS) 审核方面面临着挑战。该公司的透皮 GFR 测量系统 (TGFR) 是 III 类组合设备,这意味着它必须通过 FDA 上市前批准 (PMA) 途径。此外,MediBeacon 还与多个设备开发和制造组织签订了合同,其设备的药物成分必须符合 21 CFR 第 4 部分 - 组合产品法规。该公司很快意识到纸质质量管理体系或通用软件解决方案不足以克服所需的监管和管理障碍。
解决方案
MediBeacon 从纸质 QMS 过渡到 Greenlight Guru,这是一种专为设备制造商和开发商设计的电子 QMS (eQMS)。该公司选择 Greenlight Guru 是因为其直观的用户体验、ISO 13485 合规性及其提供的验证包。 Greenlight Guru 的客户成功团队(被称为“专家”)推动了过渡过程,他们帮助 MediBeacon 将所有内容引入系统,以便于编辑和维护最新文档。专家们还在整个入职过程中提供了宝贵的支持,帮助 MediBeacon 自信而高效地使用该软件。
运营影响
数量效益
Case Study missing?
Start adding your own!
Register with your work email and create a new case study profile for your business.
相关案例.
Case Study
Remote Temperature Monitoring of Perishable Goods Saves Money
RMONI was facing temperature monitoring challenges in a cold chain business. A cold chain must be established and maintained to ensure goods have been properly refrigerated during every step of the process, making temperature monitoring a critical business function. Manual registration practice can be very costly, labor intensive and prone to mistakes.
Case Study
Hospital Inventory Management
The hospital supply chain team is responsible for ensuring that the right medical supplies are readily available to clinicians when and where needed, and to do so in the most efficient manner possible. However, many of the systems and processes in use at the cancer center for supply chain management were not best suited to support these goals. Barcoding technology, a commonly used method for inventory management of medical supplies, is labor intensive, time consuming, does not provide real-time visibility into inventory levels and can be prone to error. Consequently, the lack of accurate and real-time visibility into inventory levels across multiple supply rooms in multiple hospital facilities creates additional inefficiency in the system causing over-ordering, hoarding, and wasted supplies. Other sources of waste and cost were also identified as candidates for improvement. Existing systems and processes did not provide adequate security for high-cost inventory within the hospital, which was another driver of cost. A lack of visibility into expiration dates for supplies resulted in supplies being wasted due to past expiry dates. Storage of supplies was also a key consideration given the location of the cancer center’s facilities in a dense urban setting, where space is always at a premium. In order to address the challenges outlined above, the hospital sought a solution that would provide real-time inventory information with high levels of accuracy, reduce the level of manual effort required and enable data driven decision making to ensure that the right supplies were readily available to clinicians in the right location at the right time.
Case Study
Gas Pipeline Monitoring System for Hospitals
This system integrator focuses on providing centralized gas pipeline monitoring systems for hospitals. The service they provide makes it possible for hospitals to reduce both maintenance and labor costs. Since hospitals may not have an existing network suitable for this type of system, GPRS communication provides an easy and ready-to-use solution for remote, distributed monitoring systems System Requirements - GPRS communication - Seamless connection with SCADA software - Simple, front-end control capability - Expandable I/O channels - Combine AI, DI, and DO channels
Case Study
Driving Digital Transformations for Vitro Diagnostic Medical Devices
Diagnostic devices play a vital role in helping to improve healthcare delivery. In fact, an estimated 60 percent of the world’s medical decisions are made with support from in vitrodiagnostics (IVD) solutions, such as those provided by Roche Diagnostics, an industry leader. As the demand for medical diagnostic services grows rapidly in hospitals and clinics across China, so does the market for IVD solutions. In addition, the typically high cost of these diagnostic devices means that comprehensive post-sales services are needed. Wanteed to improve three portions of thr IVD:1. Remotely monitor and manage IVD devices as fixed assets.2. Optimizing device availability with predictive maintenance.3. Recommending the best IVD solution for a customer’s needs.