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2025AI & MLVirelio client
Medical Technical File Builder
NLP trained on medical regulation that drafts the technical files behind FDA, CE and ISO approval.
- Per dossier, down from 3 months
- 1 week
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.
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.