The Flexible eQMS Platform for Medical Device Development

Build your eQMS to suit you

FDA 21 CFR 11 820 | ISO 13485 | MHRA GXP Data
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Success in the medical device sector depends not just on a great product. It depends on the rigour of your processes, good operational governance, and rock solid design controls. Our platform for a Cloud-based Quality Management System helps you get there.


Scale, focus and get to market quicker

Many eQMSs are clunky and prescriptive. But in order for medical device development to succeed, your quality management system should be scaled to the size, complexities and requirements of your company. No more, no less. Only then, you can focus on product safety and getting to market quicker. This is exactly what Cognidox allows you to do.


Build your eQMS to suit you

Our engineers created a cloud-based QMS platform built on a document management system with a lean approach to design controls and quality compliance. We allow you to continue to use your existing procedures and documentation but, on a complaint, electronic platform. Then we add all the extras to take your quality management system to the next level. This way, you build your eQMS to suit you.


Standard features


Document control


Workflow automation


Training tools


Software validation


Compliant e-signatures


Quality modules

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What do you really need?

Cognidox offers you a cloud-based QMS platform that won't slow you down and won't cost the earth. Everything you need - nothing more. Watch the video!

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With Cognidox, FDA and GxP compliance simply becomes ‘the way you do things’

  1. Compliance tools
    Meet the requirements of FDA 21 CFR 11, FDA 21 CFR 820, ISO 13485 and the MHRA GXP guidelines. Compile and publish your Design History File and other technical files at the touch of a button.

  2. Rock-solid change control
    Ensure your change control management is water-tight, with phase-gating and document approval processes built into the way you work and iterate your product.

  3. Software validation
    Cognidox helps you meet all the robust demands of software validation regulations required by ISO 13485 and FDA 21 CFR 11.

How to build an eQMS for medical device development?

Build an eQMS that suits you! Download our guide to building a flexible, ISO 13485 compliant eQMS for medical device development.