AI / ML2025-01
Medical Technical File Builder
Medical device companies spend months compiling technical dossiers for regulatory approval — FDA, CE marking, ISO standards. A client asked if AI could speed this up.
Key Highlights
- I built a platform using NLP models trained on medical regulations that automatically extracts documentation requirements, generates compliance templates, and cross-references regulatory changes
- What used to take 3 months now takes about a week
- The system handles the tedious research and formatting while the compliance team focuses on review and sign-off
- 5x faster than the traditional process
Technology Stack
Core
PythonFastAPI
AI
TensorFlowNatural Language ProcessingRegulatory AICompliance Automation
Infrastructure
PostgreSQLDockerAWSDocument Processing