Do you need Greenlight Guru, Koddex, or both? The two layers of medtech compliance.

This comparison is a little different from the others, because for many medtech teams the honest answer is not "Koddex or Greenlight Guru" but "which layer is your actual problem?"

Greenlight Guru is a purpose-built eQMS for medical devices: document control, CAPA, complaints, audits, design controls workflows, with real AI capabilities now in general availability. If your bottleneck is running an ISO 13485 quality management system, Greenlight Guru is a credible, specialized answer, and we will say so in a sales call too.

Koddex operates one layer down. It is the engineering source of truth: requirements, BOM, tests, design decisions and their dependencies as one computable, versioned graph. The quality system consumes evidence; the engineering graph produces it.

The gap most medtech teams actually have

MDR technical documentation and FDA design history files are only as good as the engineering data behind them. In most Class II and III companies, that data lives in an archipelago: requirements in spreadsheets, BOM in another spreadsheet or a light PLM, test reports in folders, decisions in emails. The eQMS then documents, with great process rigor, artifacts that were assembled by hand from that archipelago.

The result is familiar: design reviews that take weeks to prepare, impact assessments rebuilt manually for every change, and audit findings not on your quality process but on the traceability of the engineering underneath it. A quality system cannot fix fragmented engineering data. It can only make the fragmentation more visible.

What each platform actually covers

Greenlight Guru: QMS processes. Document control, training, CAPA, complaints, risk management workflows, design controls as a process framework, audit management. Its object is the quality record.

Koddex: The product definition. Typed requirements linked to the components that implement them, the tests that verify them and the documents that prove them. Versioned BOM. Real-time impact analysis across the whole graph. Immutable baselines that freeze the exact configuration at design freeze or submission. Certification-ready exports that turn audit preparation from a three-week sprint into a ten-minute query.

The overlap is design controls, and even there the philosophies differ: an eQMS manages design controls as workflow steps; Koddex generates the traceability those steps require, as a by-product of engineering work rather than a documentation task.

Koddex plus a QMS: the pattern that works

The deployment pattern we see in medtech: Koddex as the engineering backbone, connected to a QMS (Greenlight Guru, MasterControl, or a lighter system) that consumes its evidence. Requirements-to-test traceability, impact analyses and configuration baselines flow from the graph into the technical documentation, and the QMS orchestrates the processes around them. Koddex integrates natively with QMS platforms, ERP and CAD, API-first.

For early-stage teams not yet ready for a full eQMS, Koddex plus a lightweight document control setup carries them credibly to their first submission, with the engineering traceability already structured.

Side-by-side