Medical Device Quality Management System

A flexible eQMS framework

What if there was a digital Quality Management System that could be exactly right-sized to your needs?

Cognidox is an electronic document management system that provides a flexible, digital framework for ISO 13485 and FDA 21 CFR 11 compliance.  It offers all the controls, tools and features that you need to store, index and structure your documentation to meet the regulation. 

With Cognidox you can build your ISO compliant QMS as a fully-featured intranet site, providing an accessible and intuitive navigation for your team. 

Under the intranet layer is a powerful electronic document management solution (eDMS) into which you upload your existing quality documents, or add them in as they are generated.

Cognidox  brings all the powerful document controls you would expect and that are required by the FDA and ISO 13485:

• Date and time stamping
• Version history
• Approval
• Access hierarchy
• Workflow management
• Electronic signatures

Clear explanation for workers and auditors

As and when your workers or auditors need to understand your procedures for dealing with CAPAs, complaints, change control and every other regulated activity, they can be just a click away from a flow chart (simply built out in Visio) that shows exactly what is required of them.

ISO 13485 and FDA 21 CFR part 820 design controls for medical devices

With a graphical eQMS your whole organisation and external auditors can see you have created the required, rigorous design process, with regular checks against user needs and provision for verification and validation at key stages.

The graphic carries deep links to the locations of the specified controlled files of user requirements and designs. By the end of your development process, you’ll have compiled the full ‘Design History File’ required by the FDA available.

CAPA forms (and more) come as standard

No need to struggle creating usable and accessible forms to capture feedback and issues from internal and external sources. 

The Cognidox eQMS provides the custom forms and reports to cover these (and other scenarios):

• Corrective and preventive actions
• Opportunities for improvement
• Complaints
• Non-conformances
• Change control

These forms are part of the solution but are flexible enough for you to edit as you need to or use as the basis for adding other forms. You can create drop-down menus, labels, free form boxes and the like.

Training documentation and attestation

How do you prove to auditors that training is undertaken and that your team has been alerted to changes in process, procedure and regulation?

Cognidox helps you automate training attestation. It can automatically require staff to self certify their understanding of SOPs and other requirements at defined intervals. It can trigger a certification process when new quality documentation is introduced or old documentation is revised.

Flexible QMS software for medical device developers

For those businesses who want to keep control over their own processes but still save the time of designing and documenting a QMS completely  ‘from scratch’, Cognidox’s digital framework is the answer. 

It’s a system that can cut out the wasted time of a manual review and approval process, strippping out unnecessary bureaucracy from the way you work, and keeping you laser-focused on producing the documentation that you really need to drive your product forward.

• Provides strong visualisations to facilitate training and auditing
• Allows you to make changes to templates to fit the way you work - not the other way around
• Comes with customisable forms as standard for non conformances, complaints, engineering change control and other key activities
• All underpinned by a powerful eDMS