Design Controls are the gated, traceable steps (user needs → inputs → outputs → verification → validation → transfer) required by ISO 13485 and FDA 21 CFR 820 to prove a device was developed to plan. They reduce “wrong-version” risk, show regulatory intent, and protect product quality and revenue.

Cognidox provides the framework and tools to build the DHF from project start: project-level templates and Document Holders let you define the required artefacts for each phase, and documents are deep-linked to the project and to the exact controlled versions. As you add documents and complete approvals, the DHF is created and maintained as a live, auditable record. Once the DHF structure and templates are in place and the source documents are added, Cognidox can assemble coherent DHF evidence packs (with version history, approval manifests and traceability) for review or audit — but the DHF itself is built and populated through the project workflow rather than being magically generated without configuration.

Yes. Requirements, risk mitigations (ISO 14971), verification and validation artefacts are linkable in Cognidox so you can produce a living traceability matrix. That linkage supports both design verification and the evidence auditors expect for V&V and risk management.

Use Cognidox Programme Plans / Document Holders to define the exact deliverables for each gate. Document Holders show what must be present/approved before a STOP→GO, and routing/controls prevent a phase progressing until every required artefact is authorised. It’s phase gating that’s flexible, repeatable and non-prescriptive.

Master CAD, PCB and binary files are stored under control and can be paired with a PDF/image rendition so reviewers who lack CAD tools can view and comment. Cognidox also supports structured handling of software artefacts and integration with build/SCM processes so releases, tapeout data and binaries enter the DHF in a controlled, auditable way.

Routing rules (set on category/document type) define reviewers, approvers and required sign-off sequences. Each review/save is timestamped and versioned; final closure is by competent persons using role-based e-signatures with re-authentication. All actions are preserved in an immutable audit trail.

You should treat the DHF as part of the project from day one, but Cognidox provides import tools and template mapping so you can bring legacy files into a structured DHF. Imports can preserve version history and be staged into pilot areas for validation before publishing into the live DHF.

Change records (ECR/ECO, deviations, concessions) are form-based and link back into requirements, verification artifacts and SOPs. Impact analysis shows exactly what a change touches; approved changes can update documents, spawn retraining and feed CAPA—keeping the DHF coherent across revisions.

Cognidox turns audits into a guided tour: click from programme map → document → version → approval manifest. On-demand evidence packs deliver the exact set of artefacts auditors request, complete with timestamps, signer reasons and traceability — the DHF is the single source of truth.

Cognidox is configurable, not prescriptive: use only the gates, templates and workflows you need. Templates, recommended titles, routing rules and programme plans give repeatability without bureaucracy, so regulation-critical controls exist where required but don’t force unnecessary steps in low-risk areas. This keeps the system compliant and efficient.