cognidox

A lean electronic Quality Management System tailored for medical device and high-tech product development.

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Overview

Cognidox is a cloud-based lean eQMS and document management system designed to support regulated industries like medical devices, biotech, and high tech. It offers configurable workflows, design controls, e-signatures, training management, and compliance tools for standards such as ISO 13485 and FDA 21 CFR Part 11.

Updated Oct 16, 2026.

What cognidox has

Support

A dedicated expert who helps your team get the most out of the product.
Get help from the support team by writing to them via email.
Real people you can contact when you need help with the tool.
Help moving your existing content and data into the tool from another platform.
Guided setup and training to help new users get started with the tool.

Pricing

Try the paid product for a limited time before committing to a subscription.
A product demonstration available to prospective customers who want to evaluate the tool.

Extras

Pre-built starting points you can edit to fit your own needs.
An educational resource that explains a topic and helps readers build their knowledge.

Integrations

Docusign

Key Features

Document control

Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.

Learning management

The Cognidox Learning Management System (LMS) provides employees, line managers, training managers, and quality managers with all the tools and information that they require to ensure both organisation and legal compliance

Document migration

Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system.

Development records

All the eQMS tools you’ll need to record and evidence your entire development process - from discovery to clinical research, regulatory approval and post-market surveillance.

Pros

Configurable and scalable to support from small teams to large enterprises with 2000+ users.
Supports compliance with multiple regulatory standards including FDA 21 CFR Part 11, ISO 13485, MDSAP, and GxP requirements.
Integrated e-signatures and audit trails enhance regulatory audit readiness.
Includes a built-in Learning Management System to manage training and assessments.
Flexible design controls and phase gating support complex product development workflows.

Cons

Pricing details beyond the free Starter plan require direct contact and are not fully transparent online.
Primarily focused on regulated industries, may be less suitable for non-regulated sectors.
No explicit mention of mobile app availability or offline access.
Implementation and onboarding may require dedicated support and configuration.
Limited public information on integrations beyond DocuSign and API availability.

Frequently Asked Questions

Community reviews (0)

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Community reviews (0)

Write a review

No written reviews yet. Be the first to share your experience.

What cognidox has

Support

A dedicated expert who helps your team get the most out of the product.
Get help from the support team by writing to them via email.
Real people you can contact when you need help with the tool.
Help moving your existing content and data into the tool from another platform.
Guided setup and training to help new users get started with the tool.

Pricing

Try the paid product for a limited time before committing to a subscription.
A product demonstration available to prospective customers who want to evaluate the tool.

Extras

Pre-built starting points you can edit to fit your own needs.
An educational resource that explains a topic and helps readers build their knowledge.

Integrations

Docusign

Key Features

Document control

Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.

Learning management

Document migration

Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system.

Development records

All the eQMS tools you’ll need to record and evidence your entire development process - from discovery to clinical research, regulatory approval and post-market surveillance.

Pros

Configurable and scalable to support from small teams to large enterprises with 2000+ users.
Supports compliance with multiple regulatory standards including FDA 21 CFR Part 11, ISO 13485, MDSAP, and GxP requirements.
Integrated e-signatures and audit trails enhance regulatory audit readiness.
Includes a built-in Learning Management System to manage training and assessments.
Flexible design controls and phase gating support complex product development workflows.

Cons

Pricing details beyond the free Starter plan require direct contact and are not fully transparent online.
Primarily focused on regulated industries, may be less suitable for non-regulated sectors.
No explicit mention of mobile app availability or offline access.
Implementation and onboarding may require dedicated support and configuration.
Limited public information on integrations beyond DocuSign and API availability.

cognidox

Overview

What cognidox has

Support

Pricing

Extras

Integrations

Key Features

Document control

Learning management

Document migration

Development records

Pros

Cons

Featured Video

Frequently Asked Questions

Community reviews (0)

Community reviews (0)

What cognidox has

Support

Pricing

Extras

Integrations

Key Features

Document control

Learning management

Document migration

Development records

Pros

Cons

Featured Video

Frequently Asked Questions

Community reviews (0)