Cognidox
cognidox.com
What it is
Cognidox is a document and quality management platform for product development teams, including businesses in medical devices, life sciences, and high tech. It organizes controlled documents with versioning, change management, audit trails, metadata indexing, e-signatures, and configurable approvals. For design controls, teams can set phase gates, validate designs, and assemble FDA technical documentation such as DHF, DHR, and DMR. Quality workflows cover CAPA and OFI, supplier management, complaints, non-conformance reports, and post-market surveillance. A learning management system adds skills matrices, self sign-off, quizzes, trainer assessment, and tracking of skill gaps. Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements. Its event log records timestamped actions that cannot be changed or removed, while user IDs, passwords, and configurable rights govern access. Plans start from £6,000/yr, with a 14-day supported trial; there is no free plan. The service is available on web, Windows, and API, with no mobile apps listed.
Spec sheet
- Purpose
- Cognidox is a document and quality management platform for product development teams, including medical device, life-science, and high-tech businesses.Read 11 Oct 2026 · cognidox.com
- Trial
- The pricing page includes a 14 Day Supported Free Trial across all tiers.Read 11 Oct 2026 · cognidox.com
- Integrations
- The pricing page lists a Microsoft Office plugin across tiers, DocuSign integration in Scale and above, and API integration in Scale and above.Read 11 Oct 2026 · cognidox.com
- Compliance
- Cognidox describes support for ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 11 requirements.Read 11 Oct 2026 · cognidox.com
- Headquarters
- The company lists its address as Eagle Labs, 28 Chesterton Road, Cambridge, CB4 3AZ, UK.Read 11 Oct 2026 · cognidox.com
- Founded
- 2008Read 28 Sep 2026 · cognidox.com
- 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.Read 11 Oct 2026 · cognidox.com
- Company history
- Cognidox says Paul Walsh and Vittal Aithal spun out the Doxbox product as Cognidox in 2008.Read 11 Oct 2026 · cognidox.com
- 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.Read 11 Oct 2026 · cognidox.com
- 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.Read 11 Oct 2026 · cognidox.com
- Document control
- The platform provides version control, change management, audit trails, configurable approval workflows, metadata indexing, and integrated e-signatures.Read 11 Oct 2026 · cognidox.com
- Quality workflows
- Quality modules include CAPA and OFI, supplier management, complaint handling, non-conformance reports, and post-market surveillance.Read 11 Oct 2026 · cognidox.com
- Training
- Its learning management system includes skills matrices, self sign-off, quizzes, trainer assessment, and skill-gap tracking.Read 11 Oct 2026 · cognidox.com
- Trial support
- During the trial, Cognidox says it provides setup, training, and dedicated technical support, including help over Zoom.Read 11 Oct 2026 · cognidox.com
Plans and prices
Enterprise Priced on request Custom; contact for pricing Custom user limit · Everything in Pro · Enterprise Programme · Disaster Recovery Virtual Machine (DVRM) Read 11 Oct 2026 · cognidox.com
Growth Price not published 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 Read 11 Oct 2026 · cognidox.com
Pro Price not published Annual subscription starting from £6,000 per year; tier price not stated 100 user limit · Everything in Scale · Dedicated account management · Extranet Read 11 Oct 2026 · cognidox.com
Scale Price not published 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 Read 11 Oct 2026 · cognidox.com
Starter Price not published 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 Read 11 Oct 2026 · cognidox.com
Strong points and limits
Strong points
- Version control and configurable approval workflows
- Design controls include DHF, DHR, and DMR assembly
- Quality workflows include CAPA and supplier management
- 14-day supported free trial across tiers
Limits
- Plans start from £6,000/yr
- No free plan
- No mobile apps listed
- Starter plan is limited to 5 users
Who it suits
Cognidox suits product development teams in medical device, life-science, and high-tech businesses that need document control alongside quality, design, and training workflows. Its listed standards support may also matter to teams working with the named requirements.
Verdict
Cognidox brings controlled documents, quality processes, design controls, and training into one platform for product development teams. Before choosing a tier, account for its starting price and the listed user limits.
Where Specifiction places it
- Quality Management Software#12 of 377.9
- Document Management Software#22 of 638.0