What is the medical device technical file? What should it contain and how should it be structured? ...
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
Document controls
Bring order to your development, ensure documents are created, approved, distributed, indexed, and archived in a solid and systematic way.
Version control
Change management
Audit trails
Configurable approval workflows
Metadata indexing
Integrated e-signatures (FDA 21 CFR Part 11 compliant)
Design controls
Gather and control your design inputs and outputs in one place, stage gate your processes to continually validate designs and manage risk. Automate and bulletproof your design documentation for frictionless compliance:
Flexible phase gating
Design validation
Assemble FDA technical documentation in real-time (DHF, DHR, DMR)
Quality modules
A configurable suite of features to manage your quality processes to drive continuous improvement and seamless regulatory compliance:
Training matrices
Complaints handling
Non-conformance reports
CAPA forms
Post market surveillance
Compliance
All the tools you need to gain ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, but flexible and configurable. Cognidox helps compliance become the ‘way you do things’.
Assemble required technical documentation in real-time
Publish DHF, DHR and DMR on demand
Integrate FDA compliant E-signatures
CAPA reporting built around the way you work
Software validation
Providing improved visibility and control for the development process for Semiconductors and medical device businesses.
A flexible eQMS platform designed for your medical device development or IVDR compliance. Validated for ISO 13485 with quality modules, eSignatures and training matrixes built in.
Our Lean DMS brings you centralised control and oversight. It ensures your product development process is consistent, sustainable, and continually improving.
A single platform on which you can provide unlimited clients with their own individual eQMS. You can clone a QMS structure and templates to have your clients set up in minutes.
Cognidox helps you rapidly migrate from paper, Google Docs or OneDrive, to a structured document management system. We’ve helped hundreds of businesses bring their documents and process under control, helping them innovate faster and repeat development success time and again.
We are consistently rated outstanding by ISO, and I attribute 80% of that to the structure that Cognidox brings.
The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.
Once you get your head around it, the system is easy to use. Great audit trail and access control.
User-friendly and very good customer support.
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 saving us time with the manual processes of document control and scheduling.
What’s great is Cognidox doesn’t require you to work in a particular way. You can decide how you want to run your engineering, development or quality flows. Rather than imposing a way of doing things, Cognidox supports the way you want to do it.
Cognidox is easy to use and simplifies processes! The support and training provided are fantastic
It is a joy to configure and work with the system on a daily basis. There are new features implemented frequently. If I had the chance to develop a DMS, it would most likely be like Cognidox.
A great value product with excellent features and unparalleled support.
Cognidox was introduced as a mandate, but it grew organically throughout the company, as users began to realise it could solve more problems.
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.
Just wanted to say what great support Cognidox provides - questions are answered promptly and difficulties are always overcome.
Starting with an obligation-free demo, if we’re the right fit for you we’ll offer a 60 day free trial of our platform. When you choose us as your partner, we’ll help you migrate data and configure the platform, with a dedicated account manager to look after you as you grow.
See if Cognidox can help you by scheduling a no-obligation, tailored demo
Set up a free 60 day live trial to test the solution with real users and processes
We’ll help you configure your system, migrate your data and train your team
A dedicated Account Manager will support you as you scale (our average response time is under 20 minutes)
Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.
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