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Choose a flexible eQMS platform designed for your medical device development or IVDR compliance

FDA 21 CFR 11

FDA 21 CFR 820

ISO 13485

MHRA GXP Data

Success in the medical device sector depends not just on a great product but on the rigour of your processes, good operational governance, and rock solid design controls.

 
Some med tech eQMS options are clunky and prescriptive. They can force you to change the way you work just to match their software's defined processes. They can tie you up for months with unnecessary complexity.
 
Find a solution that is adaptable, scalable, and designed to flex with your needs. With Cognidox, document control, workflow automation, compliant e-signatures and software validation come as standard. And if you already have a certified QMS in place, we'll minimise the process changes you'll need to make to adopt the platform.
 
Cognidox is a document management system designed for complex product development with a lean approach to design controls and quality compliance. We have a proven track record of helping innovative companies scale and succeed.

Document Management for Medical Devices:

Use Cognidox to record, store and index every document from ideation through to release and upgrade. Then publish your Design History File at the ‘touch of a button’.

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

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.

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.

Software Validation

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

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