Tracewell AI

🚀 Agile Compliance for Modern Medical Software Teams Tracewell AI transforms how software-first medical device companies approach FDA compliance. We bridge the gap between fast-moving development teams and regulatory requirements by automatically extracting Design History Files (DHF) from your existing development workflow. What We Do: ✓ Connect GitHub, Jira, and Linear to generate FDA-ready documentation ✓ Transform product requirements into compliance documentation automatically ✓ Create real-time traceability matrices without context switching ✓ Help teams prepare 510(k) submissions faster and more accurately Built for Cross-Functional Teams: Our platform serves the entire product development ecosystem - engineers maintain code in GitHub, product teams manage in Jira/Linear, designers create in Figma, and regulatory gets automated DHF documentation. Everyone stays in their preferred workflow while maintaining compliance. Why Tracewell AI: Unlike traditional compliance tools built for legacy processes, we're designed for software-first teams building Software as Medical Devices (SaMD). Our AI-powered approach reduces manual documentation burden while ensuring audit-ready outputs that align with ISO 13485 and FDA 21 CFR 820.30 requirements. Perfect for: - Medical device startups preparing for their first FDA submission - Scale-ups transitioning from manual compliance processes - Established companies modernizing their regulatory workflows - Lean teams without dedicated regulatory specialists The Result: Teams ship compliant medical software faster, with less rework, and greater confidence in their regulatory submissions. Ready to accelerate your path to FDA clearance? Let's connect and explore how Tracewell AI can streamline your compliance journey. 🌐 http://www.tracewell.ai📧 Get early access today

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