Automated Traceability & Gap Detection

TraceBridge AI directly ingests complex Medical Device Software documentation (Risk Management, DHR, SRS, V&V Protocols) and performs multi-layered deterministic audits against FDA 510(k) and ISO standards. The engine replaces manual traceability matrix reviews with deterministic citations generated by a private Google Gemini semantic backend.

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. File IngestionSecure File API handles 20MB+ PDFs natively.

2. Gap GenerationSystem throttles processing to abide by rate limits.

3. Result OutputMatrix formats directly for auditor review.