Freedom251 › Quality Management Software
Cognidox
What Cognidox is
Cognidox is a document and quality management platform for product development teams in medical devices, life sciences, and high-tech. It brings document control, design controls, quality workflows, and staff training into one system. Document tools include version control, change management, audit trails, metadata indexing, configurable approvals, and e-signatures. Design controls cover phase gating and validation, with real-time assembly of FDA technical documentation such as DHF, DHR, and DMR. Quality modules handle CAPA and OFI, supplier management, complaints, non-conformance reports, and post-market surveillance. Its learning management system includes skills matrices, self sign-off, quizzes, trainer assessment, and skill-gap tracking.
Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements. The event log records time-stamped actions that cannot be altered or deleted; user IDs, passwords, and configurable rights control access. Available platforms are web, Windows, and API. Annual subscriptions start from £6,000/yr, and all tiers include a supported 14-day trial with setup, training, and dedicated technical assistance. The plan range includes user limits from 5 to 100 on Starter through Pro, while Enterprise has custom terms and a custom user limit.
Who it suits
Cognidox suits product development teams that need controlled documents, design records, quality workflows, and training management in a single platform. Its stated compliance support and FDA documentation tools are relevant to medical device and life-science businesses.
What it does well
- Tracks versions, changes, approvals, and audit trails.
- Assembles FDA technical documentation in real time.
- Includes CAPA, supplier, complaint, and non-conformance workflows.
- Training tools include quizzes and skill-gap tracking.
- Trial includes setup, training, and dedicated technical support.
What to know first
- Annual subscriptions start from £6,000/yr.
- Starter is limited to 5 users.
- No mobile apps are available.
Limits
Starter allows up to 5 users; Growth allows 30, Scale 50, and Pro 100. Enterprise has a custom user limit. The supported free trial lasts 14 days.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Starter | Annual subscription starting from £6,000 per year; tier price not stated · 5 user limit · Core document management · MS Office Plugin · Limited Access Partners · Private Workspaces · Standard Support | On request |
| Growth | Annual subscription starting from £6,000 per year; tier price not stated · 30 user limit · Everything in Starter · e-Signatures & manifests · 500-doc migration free | On request |
| Scale | Annual subscription starting from £6,000 per year; tier price not stated · 50 user limit · Everything in Growth · DocuSign integration · Learning Management System · API Integration | On request |
| Pro | Annual subscription starting from £6,000 per year; tier price not stated · 100 user limit · Everything in Scale · Dedicated account management · Extranet | On request |
| Enterprise | Custom; contact for pricing · Custom user limit · Everything in Pro · Enterprise Programme · Disaster Recovery Virtual Machine (DVRM) | On request |
As cognidox.com lists them, read 11 Oct 2026. The maker's own page has the final word.
Getting started
- Visit the Cognidox website.
- Choose a subscription tier, or contact Cognidox about Enterprise terms.
- Start the supported 14-day free trial.
- Use the trial setup, training, and technical support to get started.
- Access Cognidox through web, Windows, or its API.
Verdict
Choose Cognidox if your product development work needs linked document, design-control, quality, and training workflows. Look elsewhere if you need mobile apps or an entry price below its £6,000/yr starting point.
Questions
How much does Cognidox cost?
Annual subscriptions start from £6,000/yr. Enterprise has custom pricing.
Is there a free plan or trial?
There is no free plan. All tiers include a supported 14-day free trial.
Which platforms does Cognidox support?
The listed platforms are web, Windows, and API. There are no mobile apps.
What integrations are available?
The Microsoft Office plugin is listed across tiers. DocuSign and API integrations are included in Scale and above.
What are the user limits by plan?
Starter allows 5 users, Growth 30, Scale 50, and Pro 100. Enterprise has a custom user limit.
Which compliance requirements does it support?
Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements.
Facts from Cognidox's own pages
- 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. · cognidox.com, 11 Oct 2026
- Company history
- Cognidox says Paul Walsh and Vittal Aithal spun out the Doxbox product as Cognidox in 2008. · cognidox.com, 11 Oct 2026
- Compliance
- Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements. · cognidox.com, 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. · cognidox.com, 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. · cognidox.com, 11 Oct 2026
- Document control
- The platform provides version control, change management, audit trails, configurable approval workflows, metadata indexing, and integrated e-signatures. · cognidox.com, 11 Oct 2026
- Founded
- 2008 · cognidox.com, 28 Sept 2026
- Headquarters
- The company lists its address as Eagle Labs, 28 Chesterton Road, Cambridge, CB4 3AZ, UK. · cognidox.com, 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. · cognidox.com, 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. · cognidox.com, 11 Oct 2026
- Quality workflows
- Quality modules include CAPA and OFI, supplier management, complaint handling, non-conformance reports, and post-market surveillance. · cognidox.com, 11 Oct 2026
- Training
- Its learning management system includes skills matrices, self sign-off, quizzes, trainer assessment, and skill-gap tracking. · cognidox.com, 11 Oct 2026
- Trial
- The pricing page includes a 14 Day Supported Free Trial across all tiers. · cognidox.com, 11 Oct 2026
- Trial support
- During the trial, Cognidox says it provides setup, training, and dedicated technical support, including help over Zoom. · cognidox.com, 11 Oct 2026
Where Cognidox stands on Freedom251
- Quality Management Software#6 of 37
- Document Management Software#19 of 63