The pain

Requirements captured in docs, never connected to the product

Specs and regulatory clauses are written in Word, Confluence or a ticket tracker — and stay disconnected from the components, tests and revisions they constrain. The matrix is born stale.

Certification readiness only becomes visible at the end

Coverage gaps and missing evidence surface during the pre-submission review, not during development. The team scrambles for two weeks to back-fill what should have been current all along.

Every new certification rebuilds the same matrix from scratch

FDA, EU MDR, ISO 13485, DO-178C: each authority asks for a different cut of the same data. Without a structured backbone, every cut is a manual project on its own.

Multi-indication and multi-variant baselines drift apart

A product certified for one indication needs another variant under a partially-shared baseline. With no integrated requirement model, the variants diverge — and the certified version is no longer the one in development.

one structured graph

The Koddex way

01 / 03

Integrate every requirement into one structured backbone

Functional, performance, regulatory, customer-specific: all live in the same graph as your parts and assemblies, with explicit links to what they constrain.

02 / 03

Map each requirement to the certifications it satisfies

ISO 13485, EU MDR, DO-178C, AS9100, IEC 62304: tag the requirements that fulfill each clause. Certification coverage becomes a live metric, not an audit deliverable.

03 / 03

Track evidence as a first-class object

Every test result, every analysis report, every supplier declaration is linked to the requirements it validates. The evidence chain is built as you work — never reconstructed at the end.