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 & get to market quicker

Scale, focus & 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

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

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!

Compliance tools
Compliance-icon

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.

An introduction to Digital Document Control for Medical Device Developers

Choosing the right tools for
ISO 13485, FDA 21 Part 820
and FDA 21 CFR part 11

Mask Group 2-1-534x519

See what our customer say!

Experience Cognidox

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.

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