Medical Device R&D, Reimagined

Your 510(k) submission
shouldn't take 12 months.

Certica is an AI R&D engineer that writes your Design History Files, generates test protocols, and drafts FDA submissions. You design the device. Certica handles the documentation.

The Problem

R&D engineers spend 60% of their time on paperwork.

6-12 mo Average 510(k) documentation timeline

200+ Pages in a typical Design History File

40-60% Of an engineer's week spent writing, not building

Design History Files. Generated.

Feed Certica your requirements, design inputs, and test results. It produces FDA-compliant DHF documentation that traces every decision from user need to verified output. No more copying data between spreadsheets and Word docs.

Test Protocols. Drafted.

Certica analyzes your device specifications and generates verification and validation protocols aligned with IEC 60601, ISO 13485, and your predicate device history. Review and approve instead of writing from scratch.

510(k) Submissions. Accelerated.

From substantial equivalence arguments to performance data summaries, Certica drafts every section of your premarket notification. What took months of documentation assembly now takes weeks.

Built by engineers who lived the problem.

Certica was born from 20+ years inside a medical device R&D lab. We watched brilliant engineers spend their weeks formatting documents instead of innovating. The FDA requires rigorous documentation for good reason. The process of creating it doesn't need to be manual.

1,200+ AI-enabled devices FDA-authorized since 1995

$26.2B Projected AI medical device market in 2026

38.5% CAGR growth rate, accelerating

The next generation of medical devices will be designed faster, documented better, and cleared sooner.

Certica is how we get there.