If you are building AI Software as a Medical Device (SaMD), you already know the disconnect. Engineers live in Git, commits, and pull requests. Quality and Regulatory teams live in Word, SharePoint, and manual spreadsheets.
When audit time comes or a 510(k) submission is due, teams spend weeks manually reconciling design history files, tracking down eSignatures, and verifying that every requirement has a passing test. It is an administrative nightmare that slows down innovation.
Today, we are changing that with the Lightworks Console and LQL (Lightworks Query Language).
Lightworks is built on the premise that your QMS should live in your repo as version-controlled Markdown. Now, with the Console, we are giving cross-functional teams the power to query their entire compliance history exactly like they query a database, using branch-aware, version-aware SQL.
Beyond Standard SQL: Built for Compliance
While standard SQL functions like SELECT and JOIN form the foundation of LQL, traditional databases do not understand Git history, traceability, or the specific regulatory needs of ISO 13485 and IEC 62304.
We extended SQL with four unique QMS primitives:
- TRACE (Automated Coverage): Instead of building massive
JOINtables to check coverage, LQL usesTRACE. A simple query likeTRACE requirements -> testsinstantly returns your full traceability matrix. When preparing a PR, developers can run this to instantly verify that no test coverage was dropped. Pro tip:TRACEalso works across Linear and Jira integrations; a query likeTRACE tests -> linearlinks your test coverage straight to the tickets that implement or mitigate them. - GRAPH (Relational Mapping): Medical device risk management is complex.
GRAPHallows you to traverse multi-layered relationships seamlessly, mapping Hazards to Harms to Mitigations to System Requirements, ensuring end-to-end risk control is fully documented.
Every result set is actionable, not just readable. Click any record returned by a query and it opens in a side peek, where you can view and edit its contents without leaving the Console. Spot a gap in your traceability matrix? Fix it on the spot.
The Lightworks Advantage: Time Travel Queries
Traditional QMS platforms only allow you to query and search your records in their current state. They fall apart when you need to look at your device's history. This is a critical failure point when building Design History Files (DHFs) for FDA submission and clearance.
Lightworks solves this with time travel queries that are completely unique to our platform:
- AT (Point-in-Time Audits): Auditors rarely ask what your system looks like today; they ask what it looked like when you shipped a specific version. When an auditor asks for a record from a previous release, you can use
AT TAG 'v2.5'orAT COMMIT. This makes retrieving historical records trivial and getting answers to auditors incredibly fast, which ultimately accelerates your clearance. - BETWEEN (Tracking Drift): Need to know exactly what changed between two releases?
BETWEEN TAG 'v1.0' AND 'v2.0'lets QMs instantly isolate QMS drift. You can see the exact delta in your compliance state, making impact analysis and regression tracking immediate.
One Console, Every Discipline
The beauty of the Lightworks Console is that it creates a single source of truth for the entire team. Software engineers, AI researchers, quality managers, and regulatory affairs all run queries against the same compliance history, through the MCP server, the Console UI, or CI. Nobody is stuck waiting on someone else to export a spreadsheet, parse code, or hunt down a record from a past release. Everyone gets a direct, real-time view into the same source of truth, in whatever form their role needs.
Stop managing quality by spreadsheet. Start querying it.
Read the full documentation on Databases and the Console.
Ready to time travel query your QMS? Sign up for Lightworks.