Cognidox
Cognidox is a document and quality management platform for product development teams, including businesses in medical devices, life sciences, and high tech.
What Cognidox is
Cognidox is a document and quality management platform for product development teams, including businesses in medical devices, life sciences, and high tech. It combines document controls such as version tracking, change management, audit records, configurable approvals, metadata indexing, and e-signatures. Design-control tools cover phase gates and validation, and can assemble FDA technical files such as DHF, DHR, and DMR. Quality workflows include CAPA and OFI, supplier management, complaint handling, non-conformance reporting, and post-market surveillance. Its learning system supports skills matrices, self sign-off, quizzes, trainer assessments, and skill-gap tracking. Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11. Its event log records time-stamped activity that cannot be changed or removed, with access governed by user credentials and configurable rights. The service runs on web, Windows, and API. Annual subscriptions start from £6,000/yr, with a 14-day trial; there is no free plan. No mobile apps are listed.
Good
- Tracks document versions and audit activity.
- Supports configurable approval workflows and e-signatures.
- Includes quality and design-control workflows.
- Trial includes setup, training, and technical support.
- Available through web, Windows, and API.
Watch out
- No free plan.
- Annual subscriptions start from £6,000/yr.
- No mobile apps are listed.
- Starter plan is limited to 5 users.
Who it suits
Cognidox suits product development teams that need document control, quality workflows, design controls, and training management. It is especially relevant to medical device, life-science, and high-tech businesses.
Verdict
Cognidox brings document control, quality processes, design controls, and staff training into one platform. Its listed starting price and lack of mobile apps are worth weighing against the workflows and compliance support a team needs.
Plans and prices
From Cognidox's own pricing page, checked 11 Oct 2026.
| Plan | Price | What it gives you |
|---|---|---|
| Enterprise | Priced on request | Custom user limit · Everything in Pro · Enterprise Programme · Disaster Recovery Virtual Machine (DVRM) · Custom; contact for pricing |
| Growth | — | 30 user limit · Everything in Starter · e-Signatures & manifests · 500-doc migration free · Annual subscription starting from £6,000 per year; tier price not stated |
| Pro | — | 100 user limit · Everything in Scale · Dedicated account management · Extranet · Annual subscription starting from £6,000 per year; tier price not stated |
| Scale | — | 50 user limit · Everything in Growth · DocuSign integration · Learning Management System · API Integration · Annual subscription starting from £6,000 per year; tier price not stated |
| Starter | — | 5 user limit · Core document management · MS Office Plugin · Limited Access Partners · Private Workspaces · Standard Support · Annual subscription starting from £6,000 per year; tier price not stated |
The facts
Each one read from Cognidox's own pages, with the date it was checked.
What it does
- Audit trail and access
- The compliance page says the event log records time-stamped actions and cannot be amended or deleted, while access is controlled through user IDs, passwords, and configurable user rights.checked 11 Oct 2026
- Compliance
- Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements.checked 11 Oct 2026
- Customer support
- Customers can access a knowledge base and contact the Cognidox Support Team; logged-in customers can download product updates, release notes, and documentation.checked 11 Oct 2026
- Design controls
- Design-control features include flexible phase gating, design validation, and real-time assembly of FDA technical documentation such as DHF, DHR, and DMR.checked 11 Oct 2026
- Document control
- The platform provides version control, change management, audit trails, configurable approval workflows, metadata indexing, and integrated e-signatures.checked 11 Oct 2026
- Integrations
- The pricing page lists a Microsoft Office plugin across tiers, DocuSign integration in Scale and above, and API integration in Scale and above.checked 11 Oct 2026
- Purpose
- Cognidox is a document and quality management platform for product development teams, including medical device, life-science, and high-tech businesses.checked 11 Oct 2026
- Quality workflows
- Quality modules include CAPA and OFI, supplier management, complaint handling, non-conformance reports, and post-market surveillance.checked 11 Oct 2026
- Training
- Its learning management system includes skills matrices, self sign-off, quizzes, trainer assessment, and skill-gap tracking.checked 11 Oct 2026
The company
- Company history
- Cognidox says Paul Walsh and Vittal Aithal spun out the Doxbox product as Cognidox in 2008.checked 11 Oct 2026
- Founded
- 2008checked 28 Sep 2026
- Headquarters
- The company lists its address as Eagle Labs, 28 Chesterton Road, Cambridge, CB4 3AZ, UK.checked 11 Oct 2026
Money
- Trial
- The pricing page includes a 14 Day Supported Free Trial across all tiers.checked 11 Oct 2026
- Trial support
- During the trial, Cognidox says it provides setup, training, and dedicated technical support, including help over Zoom.checked 11 Oct 2026
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