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Greenlight Guru > 实例探究 > Avenda Health 利用 Greenlight Guru 的 QMS 加速 SaMD 产品发布
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Avenda Health Accelerates SaMD Product Launch with Greenlight Guru’s QMS

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
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。
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。
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。
运营影响
  • The partnership with Greenlight Guru has had a transformative impact on Avenda Health's operations. The QMS software, designed specifically for MedTech companies, has not only provided a robust solution for managing quality but also offered a wealth of resources for industry education. The SOP templates, courses, training workshops, and access to the Greenlight Guru Academy have been instrumental in enhancing the team's knowledge and skills. The user-friendly nature of the software has made it easy for team members of all skill levels to get started, significantly improving collaboration and efficiency. Furthermore, the ability to link to any document in the software has been a game-changer, streamlining document management and saving considerable time. With their second 510(k) clearance obtained faster, Avenda was able to bring their product to market more quickly and efficiently, all while ensuring compliance with regulatory requirements.
数量效益
  • Greenlight Guru's QMS enabled Avenda to obtain their second 510(k) clearance faster, allowing them to bring their product to market more quickly.
  • The user-friendly nature of Greenlight Guru's QMS allowed for easy learning across all skill levels, saving significant time in training.
  • The ability to create links to anything in the software increased efficiency in collaboration and document management.

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