技术
- 分析与建模 - 机器学习
- 平台即服务 (PaaS) - 设备管理平台
适用行业
- 教育
- 医疗保健和医院
适用功能
- 产品研发
- 质量保证
用例
- 虚拟培训
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Avenda Health 是一家医疗技术公司,利用人工智能为医生提供比传统 MRI 更精确的癌症图谱。这种清晰度的提高有助于医生更好地了解疾病的严重程度,从而改善患者的治疗结果。该公司的使命是改善被诊断患有前列腺癌的男性的生活质量、治疗计划和结果。为了实现这一目标,Avenda 开发了一种新颖的设备,需要强大且直观的质量管理系统 (QMS) 才能将其推向市场。该公司的团队分散在全国各地,这使得产品开发和质量方面的协作和协调成为一项重大挑战。
挑战
Avenda Health 是一家致力于改善前列腺癌男性的生活质量和治疗结果的公司,在将其新型设备推向市场时面临着巨大的挑战。该公司的团队分散在全国各地,如果没有统一的事实来源,产品开发和质量团队之间的协作就会变得困难。此外,应对复杂的监管环境,将其软件即医疗设备 (SaMD) 产品推向市场是一项艰巨的任务。跟上需求和文档,同时确保各地团队保持一致,是 Avenda 的首要任务。然而,事实证明,远程协作和及时更新必要的文档是一项重大挑战。
解决方案
Avenda Health 与 Greenlight Guru 合作,利用其专为医疗科技公司设计的质量管理体系 (QMS)。 Greenlight Guru 的 QMS 不仅提供了强大的质量管理解决方案,还提供行业教育、标准操作程序 (SOP) 模板、课程、培训研讨会以及 Greenlight Guru 学院的访问权限。这套全面的资源极大地改善了 Avenda 在医疗设备开发方面的业务协作。用户友好且易于学习的系统使 Avenda 能够创建到软件中任何内容的链接,这被证明是一个游戏规则的改变者。 Greenlight Guru 的 eQMS 和审计就绪 SOP 模板帮助 Avenda Health 实施其质量体系、简化合规性并更快、更高效地进入市场。
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