Lightworks Labs is building the quality management system that AI SaMD teams actually want to use: version-controlled, auditable, and designed around the way engineers and quality managers work together.
Quality Management Systems were built for hardware medical devices. Binders, SOPs, change control boards, paper signatures. Tools like Greenlight Guru and SharePoint made sense when your device was a catheter or an implant.
Medical devices are increasingly software. And that software is increasingly AI. The teams building it live in Git. Their source of truth is a pull request, not a PDF. Their design history is a commit log. Their quality team is trying to get FDA clearance using tools that were never designed for any of this.
Lightworks starts from a different premise: Git is already a quality management system. You just need someone to connect the dots. Everything Lightworks does, the editor, the audit trail, the eSignatures, the DHF compiler, is built on top of the version control your engineers already use every day.
Your QMS should be as close to your code as possible. Markdown in Git is the right format: diffable, auditable, readable by anyone, hostable anywhere.
The same system should work for both. Commits and change requests. Branches and drafts. One QMS, two vocabularies, zero retraining for the auditor.
Your Quality Manual belongs to you. If you leave Lightworks tomorrow, every artefact, every signature, every audit log stays in your repository. Plain markdown. Forever.
We're a small team based in California, currently in private beta with a small group of AI SaMD teams who are helping us shape the product.
If you're building an AI-enabled medical device and living the QMS pain firsthand, we'd love to talk. We're not selling yet. We're learning. The best thing you can do is book a call and tell us what's actually broken.
But if you care deeply about making software development safer and want to be first in line, drop us a line anyway.