Stop Q-Sub Engineering Drift.

Never miss an FDA Q-Sub commitment.

TraceBridge AI is an intelligent alignment engine that ingests your FDA Q-Sub meeting minutes and cross-references them against your 1,500+ page DHF. We prevent "Q-Sub Drift" by aggressively verifying that every single FDA request, constraint, and commitment is flawlessly met before your final submission.

Initialize Audit Workflow

Core Engine Capabilities

Deterministic Rules

153+ strict constraints hardcoded from IEC 62304, ISO 14971, and ISO 13485 mapped directly to a massive PostgreSQL architecture database.

Semantic Evaluation

Engine utilizes Google Gemini specialized routing to parse 100+ page clinical PDFs, extracting exact quotes to satisfy database constraints.

Verdict Triangulation

Output is merged into strict JSON generating a mathematically sound trace matrix showing complete compliance, partial reviews, or missing evidence.

Regulated Frameworks

IEC 62304:2006Active

Medical Device Software Lifecycle

ISO 14971:2019Active

Risk Management Processing

ISO 13485:2016Active

Quality Management Systems

Workflow Index

1. Q-Sub & Evidence IngestionSecure File API handles 20MB+ PDFs natively with advanced OCR fallback.

2. Alignment VerificationSystem throttles processing to abide by rate limits and ensure deterministic outcomes.

3. Traceability OutputMatrix formats directly for auditor review with full citations mapped.