Your submission PDF. In seconds.
Tag a release. Lightworks bundles the SRS, V&V reports, traceability matrix, SBOM, cybersecurity documentation, labelling, and the full signed audit trail into one paginated, pre-flight checked PDF — ready to drop into a 510(k) eSTAR.
app.lightworks.md/qms/releases/v1.4.0All 8 sections, auto-compiled
Design plan, SRS, V&V, traceability, SBOM, cybersecurity, labelling, audit log. Every section sourced from your actual artefacts — not copy-pasted.
Pre-flight blocks bad submissions
Open traceability gaps, unsigned SOPs, or critical CVEs stop the compile. You fix the issue, not the PDF.
Locked to a release tag
The compiled DHF is a cryptographic snapshot. It references the exact commit, the exact signatures, the exact SBOM. It can't be quietly edited later.
eSignatures
Every change to a controlled document flows through a Change Request and requires a verified, MFA-backed eSignature at merge.
Traceability
Lightworks traces requirements to tests to SOPs automatically and checks coverage on every commit.
Automatic SBOM
Lightworks generates a Software Bill of Materials from your dependency manifests on every push — OSV.