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Turning weeks of medical device documentation into minutes

2•feargalosull•1h ago
After several years building medical device software at ResMed, one thing consistently blocked engineering velocity: documentation.

Not design. Not testing. SOUP assessments, test reports.

For dev teams, this usually means:

Weeks of context switching away from code

Manually rewriting information that already exists in repos, tests, and tickets

Waiting on documentation before releases can move forward (monthly or yearly releases).

We’re launching Qualtate, an AI-powered platform that automates medical device software documentation, starting with:

SOUP documentation

Test reports and evidence generation

In practice, this turns weeks of manual doc work into minutes, using AI to extract, structure, and generate compliant documentation from existing engineering artifacts.

The goal isn’t to “AI-away” quality or compliance. It’s to let developers stay focused on shipping software, while still producing documentation that passes audits.

Regulatory requirements increase every year. AI adoption here feels inevitable. We’re trying to make it useful for engineers—not another tool that slows them down.

We’re opening early access to teams who want to influence what gets automated next.

Happy to answer technical questions, concerns, or skepticism.

Demo on website. https://qualtate.com/

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