FDA Approvals for AI SaMD Startups

Git-Native QMS that Feels Like Notion

Our key features

Manage Quality as Code

Automated Tracability Matrix

Engineers copying and pasting test results from their terminal will drift out of sync and jeopardize FDA approval, automate it and stay in sync

eSignatures on Merges

Approving PRs isn't enough to ensure FDA approval, you need signatures on merges to be ISO compliant

Built on top of GitHub

Your engineers are using proper version control for your code, why not for your Quality Management System and Design History Files?

How we work

Vendor Lock-in is Not Cool

01

Connect

Connect your repository

02

Write

Write your Quality Manual and SOPs

03

Automate

Automate your Tracability and SBOM

04

Approval

Version controled Design History Files

Our benefits

Version Quality Like Code

No Vendor Lock-in

Your markdown in your repo gives you full data portability. Markdown and Git are ubiquitous standards that can be edited and hosted anywhere.

No Gurus, Masters, or Vendor Lock-in

FDA Approvals for AI SaMD Startups