PreQMS is a requirements management and technical documentation platform built specifically for medical device companies pursuing FDA 510(k) clearance, IEC 62304 compliance, and ISO 13485 certification.
Unlike general-purpose QMS tools or spreadsheets, PreQMS structures your entire technical documentation set — software requirements (SRS), test cases (SSTC), test procedures (SSTP), risk analysis (ISO 14971), use case specifications, fault tree analysis (FTA), cybersecurity documentation (FDA 2023 guidance), and design specifications — in a single platform with built-in cross-module traceability.
PreQMS helps medical device teams:
• Eliminate spreadsheet chaos. Replace disconnected Word docs and Excel sheets with structured, typed modules where every requirement, test case, and risk item has a permanent ID and traceable links.
• Generate documentation with AI. Create test cases from requirements, generate use case specifications, review SRS documents for completeness and testability, and import existing Word documents — all powered by AI that understands IEC 62304 and FDA expectations.
• Maintain audit-ready traceability. One-click traceability from any requirement to its linked test cases, risk items, and design elements. When an auditor asks "show me how SRS-001 is verified," the answer is one click away.
• Baseline and track changes. Create named baselines (v1.0, v2.0) at any point. Every change after baseline is tracked at the row level with full version history, so you always know what changed, who changed it, and when.
• Visualize use cases automatically. Enter structured use case data and PreQMS generates UML use case diagrams automatically — actors, system boundaries, include/extend relationships — with SVG export for design documents.
PreQMS supports the full IEC 62304 software lifecycle from requirements through verification, with specialized modules for cybersecurity (SBOM management, STRIDE threat modeling, CycloneDX export) and fault tree analysis (interactive FTA visualization).
Designed for medical device startups and small-to-mid teams (10-150 people) who need enterprise-grade compliance documentation without enterprise-grade complexity or pricing.
