FDA Submission Time Cut from 14 Weeks to 5

Their regulatory team was drowning. Two senior RA specialists had quit in the same month — burned out from 70-hour weeks formatting 510(k) submissions. The remaining team was staring at a 14-week backlog with a competitor's product gaining FDA traction.

The Challenge

This Irvine-based heart valve manufacturer had three devices waiting for 510(k) submission. Each required 400+ pages of documentation, predicate device cross-referencing, and compliance verification. Their team of 4 regulatory affairs specialists was down to 2, and recruiting replacements in the competitive medtech market was taking months.

What We Built

We built a RAG-based document assembly pipeline trained on the company's 12 years of approved submissions and the complete FDA guidance database. The system auto-generates first-draft regulatory packages, cross-references predicate devices using NLP, and flags inconsistencies before human review. Our overnight QA team in Vietnam reviews every AI-generated section, so the US regulatory team arrives to pre-validated drafts each morning.

Results

✓Submission prep time reduced from 14 weeks to 5 weeks

✓60% reduction in regulatory team workload

✓$380K annual savings in contractor costs

✓Zero Refuse to Accept letters since deployment

✓2 devices cleared while competitors were still assembling paperwork

We went from panic-hiring contractors at $200/hr to having our RA team actually do strategic work. The AI handles the formatting and cross-referencing — our people handle the judgment calls.

— VP of Regulatory Affairs

Timeline8 weeks to deploy

Team2 AI engineers + 3 overnight QA reviewers

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