What we like
- Low published entry price: £6,000 a year for up to 5 users, and the March 2026 list worked out at about £8,400 a year for 20 users with e-signatures.
- Detailed, public clause-by-clause mappings for 21 CFR Part 11, Part 820 and ISO 13485, with re-authenticated e-signatures and an approval manifest on each PDF.
- Public knowledge base and a 400-page online manual cover document control, forms, training and the API.
- ISO 27001:2022 certified vendor (BSI), with a choice of datacentres including Frankfurt, and an on-premises option.
- Capterra reviewers rate customer service 5.0/5, and the 14-day trial is set up with your own documents and a named technical contact.
What to watch
- CAPA, NCR, change, complaint and supplier processes are configurable forms; only CAPA, NCR and change have their stages described, and complaints, supplier and audit workflows aren't documented.
- Design controls and risk are document-based: no documented trace links, risk register or IEC 62304 features.
- Starter has no e-signatures; the validation pack, SSO, API and LMS are add-ons or higher tiers, and those prices aren't published.
- All 11 Capterra reviews date from 2015–2022, before the 2025 sale to Recur Software and the 2026 repricing.
- No public terms of service, DPA or subprocessor list.
About the price: Vendor-published starting price of £6,000 a year (Sep 2026) for Starter, up to 5 users and without e-signatures; converted at the 29 Sep 2026 ECB rate. Growth (up to 30 users, with e-signatures) isn't priced; the March 2026 list was £35 per user per month with a 20-user minimum. Validation pack and SSO are unpriced add-ons.
What is Cognidox?
Cognidox is a document management and quality management system from Cognidox Ltd, based in Cambridge, UK.1 It started as “Doxbox”, an in-house tool at the chip company Virata, and was spun out in 2008.2 Medical device companies began using it in 2016, and the vendor now describes it as an eQMS for medical device development.23 It also sells to biotech, CROs and high-tech firms.1
US software group Recur Software took control of Cognidox in August 2025 and announced the purchase in October 2025.415 The vendor says it has about 20 employees and more than 200 customers.1
At its core Cognidox is a document management system with part numbers, drafts, reviews and approvals.6 Quality modules such as CAPA, NCR and engineering change requests are built as configurable forms on top of that core.78 That makes it flexible. It also means you design more of your processes yourself than in tools with fixed quality workflows.
Who Cognidox is for
It fits small and mid-sized device companies that:
- want strong, Part 11-style document control at a low price;910
- work in engineering-heavy teams with CAD, PCB and other technical files;11
- are happy to adapt CAPA, change and supplier forms to their own SOPs.127
Look elsewhere if you:
- Build software as a medical device. We found no IEC 62304 features, and no documented Jira or Git integration beyond a command-line client and an API.1113
- Want linked requirements, risks and tests. Traceability is claimed on the design-controls page, but no help article or manual page shows how it works.11
- Need complaint, vigilance or UDI workflows. Cognidox’s own ISO 13485 mapping covers regulatory reporting only by storing procedures, and expects larger firms to keep device history records in their ERP.9
Cognidox pricing
Cognidox publishes a starting price (checked 30 September 2026):10
- Starter: “Annual subscription starting from £6,000 per year”, up to 5 users, core document management. No e-signatures.
- Growth: up to 30 users, adds e-signatures and manifests, and a free migration of 500 documents. Price not published.
- Scale, Pro and Enterprise: up to 50, 100 and unlimited users; Scale adds the LMS and API. Prices not published.
Add-ons are listed without prices: validation pack, SSO, test server, extranet, LMS and APIs.10 Professional services such as admin training and workflow set-up are also unpriced. Form migration is “typically included as part of onboarding”.10
A 10-person team needs Growth, because Starter stops at 5 users. Cognidox’s archived March 2026 price list charged £35 per user per month for the plan with Part 11 e-signatures, with a 20-user minimum.14 That works out at £8,400 a year (about $11,100). A year earlier the same plan cost £30 per user per month.15 So a small team should expect roughly £6,000–8,400 a year before add-ons, plus the validation pack, whose price is also unpublished. The site’s FAQ says there are “no extra charges for modules”, which doesn’t match the current tier table.1310
Features
Document control and records
Documents get a part number and move through drafts and issues, with review, approval and a full version and review history.6 Approved documents can’t be changed, and the event log can’t be edited or deleted.9 An Office add-in lets users open and save files from Word, Excel and PowerPoint; the cross-platform version needs Office 365.16
E-signatures
Part 11 e-signatures (“extended approval”) ask the approver to re-enter a password or authenticator code, record the role and meaning, and add an approval manifest page to the PDF.179 The help center calls this an add-on, and the current pricing puts it in Growth and above.1710
CAPA, nonconformance and change control
CAPAs follow required sections from problem description and containment through root cause, actions and an effectiveness check, and a designated competent person closes them.12 NCRs use the same form model and can be linked to a CAPA.12 Change control covers engineering change requests and orders, deviations and concessions, closed with an e-signature.18 Form data can be reported on and exported to Excel.1912
Complaints, suppliers and audits
Complaints, calibration and supplier management are listed as out-of-the-box modules.13 The supplier page describes weighted scorecards and a CAPA when a supplier falls below a threshold.20 Audits are handled as documents, templates and forms.9 None of these three has a help-center article describing the workflow.
Design controls and risk
Design control uses “Document Holders”: a controlled bundle that can’t be approved until every document in it is approved, used as a phase gate.11 Cognidox says requirements, risks and tests are “linkable” into a traceability matrix. It also says the design history file isn’t “magically generated” but built through the project workflow.11 We found no risk register or ISO 14971 tool.
Training
The learning management system, launched in July 2025, assigns courses, tracks completion and runs quizzes with question pools and pass marks.212223 It is included from the Scale tier or sold as an add-on.10 Smaller plans can still record read-and-acknowledge sign-offs on documents.9
What users say
Cognidox has 11 reviews on Capterra, averaging 4.8/5, with 4.7/5 for ease of use and 5.0/5 for customer service (checked September 2026).24 G2 has only 4 reviews. All the Capterra reviews date from 2015 to 2022, before the October 2025 sale to Recur Software and the 2026 repricing, so they may not reflect the product you’d buy today.24110 Four of them were posted on 20 and 21 July 2022, and Capterra labels all four as referred by the vendor with an incentive offered.24 Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.
Reviewers most often praise support: seven of them describe fast, helpful answers.24 Three say it’s easy to use or quick to learn. Three others report a dated interface, a “not user friendly” first impression or a steep learning curve that onboarding helped with.24 We found no independent community discussion of Cognidox on Reddit or elsewhere.
Security, hosting and validation
Cognidox Ltd holds ISO/IEC 27001:2022 and ISO 9001:2015 certificates from BSI, covering its hosted systems.25 Cloud systems run in datacentres in London, Frankfurt, Newark or Tokyo, usually the one closest to your main users. Backups are encrypted, with a second copy on AWS.9 On-premises installation is possible.9
The validation pack includes a validation report, IQ and PQ templates, a worked PQ example and test evidence. The vendor also offers IQ/OQ checklists and risk templates for a CSA approach.926 It’s sold as an add-on, “primarily for Med Dev customers”.10 SAML single sign-on with Microsoft Entra ID or Google is available on higher packages or as an add-on.2710
We found no public data processing agreement, subprocessor list or terms of service.5
Buying and contract terms
The 14-day free trial is set up with you: Cognidox configures categories, document types, users and templates from your documents, gives admin training and names a technical contact.28 The vendor describes its sales path as demo, then trial, and offers live 60-minute demos.113
Subscriptions are annual, and in March 2026 they were billed quarterly in advance.1014 Documents can be exported in bulk in their original format and as PDFs, along with metadata, versions and approvals.9 A REST and SOAP API exists; its reference documentation is downloaded from inside the product.29
Because there are no public terms, we couldn’t check for price-increase caps, renewal terms, or what happens to your data if the company closes or is sold. The vendor’s own per-user list prices rose from £25 and £30 in March 2025 to £30 and £35 in March 2026, increases of 17–20%.1514 In 2026 Cognidox replaced per-user prices with user-limited tiers and stopped publishing prices above the entry tier.10 It doesn’t say how existing customers move to the new tiers. Starter is described as a “year-one onramp for new organisations”, so plan for a move to Growth after the first year.10 A team growing from 10 to 25 users stays within Growth’s 30-user limit.10 We found no user reports of renewal increases, but there are also no reviews from after the 2026 repricing. Ask for a renewal cap and a data-return clause in writing.
Cognidox says most teams have a usable baseline “within weeks”.13 One case study customer, a software company outside MedTech, was ISO certified in just over three months.30
Company and ownership
Cognidox Limited is registered in England and Wales (company 06506232) and was incorporated in February 2008.31 Until 2025 it was owned by its founders and directors.324 On 5 August 2025 Recur Software UK Ltd took control with 75% or more of the shares, and Recur’s two directors replaced the previous board.433 The sale was announced in October 2025. Cognidox said the business was profitable and would stay in Cambridge.34 Recur describes itself as a long-term owner of industry-specific software companies, backed by investors including Accel and Prosus.35 The chief executive changed in February 2026.36
The latest filed accounts, for the year to March 2025, are small-company accounts without a profit and loss statement. They show net assets of £72,287 (2024: £120,036), £479,260 cash and an average of 12 employees.32
Verdict
Shortlist Cognidox if you’re a small or mid-sized device team that mainly needs solid, affordable document control with Part 11 e-signatures, and you’re willing to shape your own quality forms. Look elsewhere if you build software as a medical device or want linked design, risk and test records. Ask for the Growth price, the validation pack price, a renewal cap and the contract terms in writing; none of them is public.
Cognidox: AI summary. Vendor website, updated 18 Jun 2026, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: About us. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎
Cognidox homepage. Vendor website, checked 30 Sep 2026. ↩︎
Companies House: Cognidox Limited, persons with significant control. Company register, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎
Cognidox: Privacy policy. Vendor legal page, last updated 13 Jul 2026. ↩︎ ↩︎
Cognidox knowledge base: The document lifecycle. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎
Cognidox knowledge base: Forms, an overview. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎
Cognidox knowledge base: Creating and assigning a form definition. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox: Compliance solutions (Part 11, Part 820, ISO 13485 mappings). Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: Pricing. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: Design controls. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: CAPAs and non-conformance. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎
Cognidox: Lean eQMS. Vendor website, checked 30 Sep 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Cognidox pricing page, archived 9 Mar 2026. Vendor website (Wayback Machine), checked 30 Sep 2026. ↩︎ ↩︎ ↩︎
Cognidox pricing page, archived 27 Mar 2025. Vendor website (Wayback Machine), checked 30 Sep 2026. ↩︎ ↩︎
Cognidox knowledge base: Using Microsoft Office applications with Cognidox. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox knowledge base: What are extended approvals?. Vendor documentation, checked 30 Sep 2026. ↩︎ ↩︎
Cognidox: Change management. Vendor website, checked 30 Sep 2026. ↩︎
Cognidox knowledge base: Creating a spreadsheet report of form data. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox: Supplier management. Vendor website, checked 30 Sep 2026. ↩︎
Training Industry: Cognidox launches integrated learning management system. Vendor press release, 8 Jul 2025. ↩︎
Cognidox knowledge base: Introducing the Cognidox LMS. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox knowledge base: Creating and managing LMS quizzes. Vendor documentation, checked 30 Sep 2026. ↩︎
Capterra: Cognidox reviews. Review site, checked 30 Sep 2026; review-source labels checked 3 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
BSI certificate IS 716399, ISO/IEC 27001:2022, Cognidox Ltd. Certificate published by the vendor, valid to May 2029. ↩︎
Cognidox: eQMS software validation. Vendor website, checked 30 Sep 2026. ↩︎
Cognidox manual: User sources and user authentication. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox: Free trial. Vendor website, checked 30 Sep 2026. ↩︎
Cognidox manual: Where to find SOAP and REST API documentation. Vendor documentation, checked 30 Sep 2026. ↩︎
Cognidox: Ranplan case study. Vendor case study, checked 30 Sep 2026. ↩︎
Companies House: Cognidox Limited (06506232). Company register, checked 1 Oct 2026. ↩︎
Cognidox Limited: financial statements for the year ended 31 March 2025. Filed accounts (Companies House), approved 16 May 2025. ↩︎ ↩︎
Companies House: Cognidox Limited, officers. Company register, checked 1 Oct 2026. ↩︎
Cognidox: Recur Software acquires Cognidox to invest in AI and growth. Vendor announcement, October 2025. ↩︎
Recur Software: FAQ. Parent company website, checked 1 Oct 2026. ↩︎
Cognidox: CEO transition. Vendor announcement, 12 Feb 2026. ↩︎
Visit the Cognidox website (made by Cognidox Ltd (part of Recur Software))
Notable features
| Built-in document editor | NoDocuments are uploaded files edited in their own apps; forms are filled in the browser |
|---|---|
| Edit in Word or Google Docs | YesOffice add-in for Word, Excel and PowerPoint; cross-platform version needs Office 365 |
| SOP templates included | Partly or add-onCAPA, NCR, change and other form templates included; SOP templates only mentioned vaguely |
| Jira or Git integration | Partly or add-onCommand-line client for source-control hooks and REST/SOAP API; no documented Jira or Git integration |
| IEC 62304 software features | Not confirmed yetNo IEC 62304 features found |
| Validation package included | Partly or add-onValidation pack with IQ/OQ/PQ templates and test evidence, sold as an add-on |
| Public API | Partly or add-onREST and SOAP API; reference docs only inside the product; Scale tier or add-on |
| Single sign-on (SSO) | Partly or add-onSAML SSO (Entra ID, Google) on higher packages or as an add-on |
| Supplier portal | YesLimited Access Partner accounts give suppliers scoped access |
| Training with quizzes | YesLMS quizzes with question pools and pass marks (Scale tier or LMS add-on) |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting feature found |
| AI features | Not confirmed yetNo AI features documented; the new owner plans to add AI |
ISO 13485 clause coverage
| Clause | Requirement | Cognidox |
|---|---|---|
| 4.2.4 | Control of documents | |
| 4.2.5 | Control of records | |
| 6.2 | Training and competence | |
| 7.3 | Design and development | |
| 7.3.9 | Change control | |
| 7.4 | Supplier qualification and control | |
| 7.5 | Production records (DMR/DHR) | |
| UDI | UDI management (EU MDR, FDA) | |
| 8.2.2 | Complaint handling | |
| 8.2.3 | Regulatory reporting (FDA MDR, EU vigilance) | |
| MDR 83 | Post-market surveillance | |
| 8.2.4 | Internal audit | |
| 8.3 | Nonconforming product | |
| 8.5.2 | Corrective action (CAPA) | |
| ISO 14971 | Risk management file | |
| IEC 62304 | Software lifecycle | |
| Part 11 | Electronic signatures |