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
- 产品研发
- 质量保证
用例
- 库存管理
- 视觉质量检测
服务
- 测试与认证
- 培训
关于客户
Greenlight Guru 的客户是在质量管理体系 (QMS)、设计控制和风险管理方面苦苦挣扎的医疗器械公司。这些公司经常因质量管理体系缺陷或过于复杂而面临不合规的风险。他们还努力在产品开发过程中记录设计控制,并跟上监管重点向风险管理的转变。 Greenlight Guru 的客户正在寻找一种简单、可扩展且灵活的解决方案,可以帮助他们有效且高效地管理质量管理体系、设计控制和风险管理。
挑战
医疗器械公司经常在管理质量管理体系 (QMS)、设计控制和风险管理方面遇到困难。挑战通常处于两个极端:要么质量管理体系有缺陷且不涉及法规,要么满足法规但过于复杂。这两种情况都会带来潜在的问题。质量管理体系不完善是必须避免的合规风险,而过于复杂的质量管理体系则可能不按规定执行,从而导致不合规。此外,公司在产品开发过程中常常难以记录设计控制,从而使流程变得不必要的复杂。医疗器械监管领域也将重点转向风险管理,要求 QMS 实施基于风险的方法。这种转变使许多公司难以跟上新的监管重点。
解决方案
Greenlight Guru 为这些挑战提供了全面的解决方案。它提供软件解决方案,帮助医疗器械公司管理其质量管理体系、设计控制和风险管理。该软件设计简单、可扩展且灵活,确保其适合公司规模。 Greenlight Guru 还提供所有必需的 QMS 程序、表格和模板,以及 QMS 培训和指导。为了应对记录设计控制的挑战,Greenlight Guru 设计了一种解决方案来简化流程,重点关注实际内容并确保完整的可追溯性。随着医疗器械监管领域将重点转向风险管理,Greenlight Guru 处于这一运动的最前沿,确保其解决方案符合当前和未来的监管观点。它允许将风险管理工作与设计控制和产品开发实践完全集成。
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