Document Management for Medical Device Development

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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 & 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

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’

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

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Customer success stories

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Cognidox is by far the easiest eDMS/eQMS to use and scores with a full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file-type and does not use thrid-party "logic", such as MFiles or alike.

Guenter Duerr, Director at Capsero

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and is saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

The system is flexible and can easily be customised to your organisational needs. The price point makes it an option for small companies that could benefit from an eQMS but do not have the funds to go with the more popular packages.

Linda Garrod, Quality Consultant at Ivdeology

The search facility sits at the top of the interface at all times and is extremely powerful and quick, and the advanced search facility is excellent.

David Ahern, CEO at Coalesce Product Development

Cognidox is easy to use and simplifies processes! The support and training provided are fantastic.

Julie Errington, Clinical Trials Manager at NCCPG

Cognidox is a very versatile software, pre-configured for many different Quality Management Systems and yet very easy to use and configure.

Fabio, CEO

The entire process from demo, training and implementation has been wonderful. The acceptance of the tool within the organization was very fast and growing by the week! This is a very versatile product and is simple to use. The workflows are very powerful and helps build compliance to several standards with ease.

Prasanna, COO

We trust Cognidox - it is robust, and with a careful setup, it is almost impossible for us to break it inadvertently. Importantly, this helps focus us on value (document content) and less on administrative process. In contrast to some consultants, it is always available, has excellent value, scales with the team and is easy to manage.