将数周的医疗器械文档处理时间缩短为几分钟
2 分•作者: feargalosull•6 个月前
在 ResMed 研发医疗设备软件的几年里，有一件事始终阻碍着工程进度：文档。<p>不是设计，也不是测试。
SOUP 评估、测试报告。<p>对于开发团队来说，这通常意味着：<p>数周的时间从代码中抽离出来<p>手动重写仓库、测试和工单中已存在的信息<p>等待文档才能推进发布（每月或每年发布）。<p>我们正在推出 Qualtate，一个由 AI 驱动的平台，可自动化医疗设备软件文档，首先从以下方面开始：<p>SOUP 文档<p>测试报告和证据生成<p>在实践中，这会将数周的手动文档工作缩短为几分钟，使用 AI 从现有的工程制品中提取、构建和生成合规文档。<p>我们的目标不是“用 AI 消除”质量或合规性。而是让开发人员专注于交付软件，同时仍然生成通过审核的文档。<p>监管要求逐年增加。在这里采用 AI 似乎是不可避免的。我们正努力让它对工程师有用——而不是另一个拖慢他们速度的工具。<p>我们正在向希望影响下一步自动化内容的团队开放抢先体验。<p>欢迎回答技术问题、疑虑或质疑。<p>网站演示：https://qualtate.com/
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After several years building medical device software at ResMed, one thing consistently blocked engineering velocity: documentation.<p>Not design. Not testing.
SOUP assessments, test reports.<p>For dev teams, this usually means:<p>Weeks of context switching away from code<p>Manually rewriting information that already exists in repos, tests, and tickets<p>Waiting on documentation before releases can move forward (monthly or yearly releases).<p>We’re launching Qualtate, an AI-powered platform that automates medical device software documentation, starting with:<p>SOUP documentation<p>Test reports and evidence generation<p>In practice, this turns weeks of manual doc work into minutes, using AI to extract, structure, and generate compliant documentation from existing engineering artifacts.<p>The goal isn’t to “AI-away” quality or compliance. It’s to let developers stay focused on shipping software, while still producing documentation that passes audits.<p>Regulatory requirements increase every year. AI adoption here feels inevitable. We’re trying to make it useful for engineers—not another tool that slows them down.<p>We’re opening early access to teams who want to influence what gets automated next.<p>Happy to answer technical questions, concerns, or skepticism.<p>Demo on website. https://qualtate.com/