Medical Device Quality Management System

A flexible eQMS framework

Cognidox’s Medical Device and IVD eQMS is a graphical interface mapped to the ISO requirements and overlaid on a robust document management system. It’s a powerful way for workers and regulators to see exactly how your business and quality system operates as one; while giving everyone access to the detail they need to do their job effectively.

Under the visual 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.

The system will show you the documentation required by the standard, so you don’t miss anything.

Meanwhile, the eQMS 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 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.

Flexible QMS software for medical device developers

When you choose a solution like Cognidox’s Medical Device and IVD eQMS nearly every element of the platform is customisable using the familiar business software Word, Excel, Powerpoint and Visio. With these tools, you can rapidly add, alter and edit standard SOPs and related QMS documents as required. 

It’s a solution that gives you a complete digital framework for an ISO 13485 compliant eQMS, which you can then populate with existing and new documentation.  It’s a digital QMS overlaid onto a robust document management system:

• Shows you what is required by ISO 13485
• Maps your process and documentation directly to those requirements
• Provides strong visualisations to facilitate training and auditing
• Allows you to make changes to fit the way you work - not the other way around
• Comes with customisable forms as standard for nonconformances, complaints, engineering change control and other key activities
• All underpinned by a powerful eDMS