Loops, layers, and the craft of shipping regulated AI. Notes on quality engineering, FDA clearance, and building the QMS your engineers actually use.
When building Software as a Medical Device, regulatory compliance is non-negotiable. How you manage that compliance is entirely up to you. Here's why data sovereignty and compliance as code matter more than ever for AI SaMD startups.
Your QMS just became a database. Meet LQL, the query language that lets AI SaMD teams TRACE coverage, GRAPH risk, and time-travel through their entire compliance history with SQL.
Lightworks didn't start as a Quality Management System (QMS). It started as an AI model to generate MRI from Ultrasound. The regulatory hurdle for AI Software as a Medical Device (SaMD) exposed a massive gap in modern compliance tooling, so I built my own. Here's how building the tool I needed became the QMS Lightworks is today.
Engineers don't hate Quality—they hate being forced out of their tools. Lightworks meets developers where they already live, turning compliance from a bottleneck into a collaborative feature.
Legacy providers treat Continuous Compliance as a buzzword. For AI SaMD, Lightworks defines it as GitHub Actions running automatically on every merge to prevent drift and upsert QMS records directly from your source code.
Lightworks now connects to Linear and Jira. Link a requirement to the issue that implements it, a risk to the ticket that mitigates it, a complaint to the bug that resolves it — and let the status flow back into your QMS without anyone copy-pasting a key.
Lightworks launched a Model Context Protocol (MCP) server. AI agents like Claude, OpenAI, and Copilot can read your QMS records directly, and propose writes through the same Git-backed audit trail you already trust for regulatory submissions.
If you're building an AI-powered medical device, you already live in Git. Your source code, your model training pipelines, your CI/CD — it all runs through repositories, branches, and pull requests. So why does your Quality Management System live in a completely separate universe of PDFs, Word docs, and folder structures that nobody trusts?
Let's be honest, nobody wants to write quality management documents. And nobody wants to write them in raw Markdown, staring at asterisks and bracket syntax in a monospace editor like it's 2009. But Markdown is the right format for regulated documents. It's plain text, so it diffs cleanly in Git. It's human-readable even without rendering. It's not locked into any vendor's proprietary format. And it plays perfectly with the Git-native compliance workflow that makes Lightworks possible.
Here's a question nobody asks during the eQMS sales demo, What happens when you want to leave? Not because you're planning to leave. But because the answer tells you everything about the power dynamic you're entering. And in the medical device QMS market, that power dynamic is almost always tilted against you.