团队们今天是如何加速符合MDR IIa标准的软件开发的？
我们正在进行一个数字健康项目，但遇到了MDR IIa的常见瓶颈——文档、质量管理、基础设施、安全工作流程等。我最近在研究不同团队如何应对这些问题。有些团队似乎选择使用预认证的平台，而不是完全内部构建（我遇到的一个例子是Actimi（https://actimi.com/en/signals）），我想了解这是否真的能节省时间，还是只是将工作转移到其他地方。
我希望能听到以下方面的经验分享：
- 在内部构建符合MDR标准的软件
- 使用预构建的框架或平台
- 自动化合规流程的部分
- 或者采取混合方式
哪些方法有效，哪些方法无效？如果你在2025-2026年重新开始，你会有什么不同的做法？
我并不是想推广什么，只是想真正了解当前生态系统的状况。
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We’re working on a digital health project and running into the usual bottlenecks with MDR IIa — documentation, quality management, infrastructure, safety workflows, etc.
I’ve recently been researching different ways teams are approaching this. Some appear to be using pre-certified platforms instead of building everything internally (Actimi (https://actimi.com/en/signals) is one example I came across), and I’m trying to understand whether this actually saves time or just shifts the work around.
I’d love to hear from people who have:<p>built MDR-compliant software in-house<p>used pre-built frameworks or platforms<p>automated parts of the compliance process<p>or taken a hybrid approach
What worked and what didn’t?
What would you do differently if you were starting again in 2025–2026?
Not trying to promote anything — genuinely trying to understand the current state of the ecosystem.