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Pre
QMS
IEC 62304 · FDA 510(k)
PreQMS AI Suite
✦ AI-powered
📄
SRS → Use Cases
IEC 62304-compliant UC generation from requirements
✓ Done
⚡
Auto-link Traceability
AI links requirements to UCs and test cases automatically
✓ Done
🔍
AI Requirement Review
Flags gaps, naming violations, missing testability
● Running
📝
SRS Document Generator
AI-drafted .docx with yellow-highlighted review sections
✓ Done
AI suite
AI that understands
regulated software.
From SRS to use cases, auto-linked traceability to AI-reviewed requirements — built for IEC 62304 and FDA 510(k) from the ground up.
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