Medical device audits can be a source of stress for developers and manufacturers. But what exactly ...
A Quality Management System right-sized to your needs
Digitise your document control
Phase gate and document your entire design process
Fast and secure information management
Ensure oversight and control with graphical business management
Detect, correct and prevent quality failures
Integrate FDA and ISO 13485 compliant e-signatures into your eQMS
Monitor and manage supply chain quality
Tracking and self-attestation made simple
Change control when it matters most
No obligation live
60-minute demo
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.
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!
With Cognidox, FDA and GxP compliance simply becomes ‘the way you do things’
The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.
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.
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.
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.
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.
Cognidox is easy to use and simplifies processes! The support and training provided are fantastic.
Cognidox is a very versatile software, pre-configured for many different Quality Management Systems and yet very easy to use and configure.
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.
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.
Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.
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