Autonomous Compliance Agent

Your quality team works 9 to 5.
Validata works all the time.

AI that autonomously generates FDA test documentation, traces design controls, and prepares regulatory submissions for medical device companies.

The Problem

Small medtech teams face the same FDA requirements as companies with 50-person quality departments. Most of the work is documentation, not innovation.

4,000+
pages in a typical 510(k) submission
$1.2B
spent on medical device QMS software in 2025
0
of those tools actually write the documents for you
How It Works

Upload your data. Validata writes the compliance.

01

Connect your test data

Import raw test results, specifications, and design inputs. Validata maps your data to FDA and ISO requirements automatically.

02

AI drafts documentation

Test reports, design history files, risk analyses, and traceability matrices generated in minutes instead of weeks.

03

Review and submit

Your team reviews AI-generated docs, makes edits, and submits. Validata monitors for regulatory changes and keeps everything current.

The Shift

Current QMS tools organize your paperwork. Validata does your paperwork.

Traditional QMS

  • Organizes documents you still have to write
  • Routes approvals through manual workflows
  • Tracks CAPAs but you investigate and resolve
  • $600/user/month for workflow management
  • Months to implement, years to master

Validata

  • Generates test docs from raw data autonomously
  • Traces design controls across the full lifecycle
  • Monitors FDA/ISO changes and flags impacts daily
  • Compiles 510(k) submission packages automatically
  • Live in days, producing documentation immediately

Compliance isn't a workflow problem. It's a writing problem.

Validata is the first AI agent that actually does the compliance work, so your engineers can get back to building devices that matter.