MAKE DESIGN CONTROLS EASY
Hello, connected information.
Cognition provides R&D and Quality Leaders with a medical device design control software platform that helps meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into structured submissions that enable them to get to market faster.
GLOBAL MEDICAL DEVICE MANUFACTURERS
RESEARCH & DEVELOPMENT LEADERS
QUALITY ASSURANCE, REGULATORY AFFAIRS, AND SYSTEM ENGINEERS
“Errors in our spreadsheets aren’t caught in time.”
“We’re missing dates for submissions because Doc1 CellAJ-278 isn’t linked to Doc17 CellAH118.”
“Time we don’t have is wasted creating, editing, and verifying spreadsheet data – all by hand.”
Your product development deserves to get error-free regulatory approvals.
As regulations continue to change, medical device manufacturers’ product development is often stalled by submission iterations, audit findings, or regulatory warnings, caused by disconnected data, manual traces, inadequate processes, and documentation errors.
• Failed audits
• 483 Citation
• Regulatory warning letters
• Rework, delays, and cost overruns
Increasing compliance complexity, changing regulations, and competitive pressures make relying on complicated spreadsheets no longer the safest approach to compliance.
OF THE TOP 6 MEDICAL DEVICE COMPANIES USE COGNITION
ISO 14971 & ISO 13485
The world has changed.
Document-based approaches to product development no longer work.
The outdated document-based approach to product design is no longer effective. It takes too long, is costly, and is prone to errors. Successful medical device manufacturers are turning to an information-driven approach, which utilizes connected data and real-time traceability that streamlines the process.
|PRODUCT DEVELOPMENT||NEW WAY|
|Words on Paper|
|Documents in Folders|
Stop editing spreadsheets.
Start information-driven design.
You shouldn’t have to recreate data that already exists.
Meet regulations easier.
Unlike other design controls systems that simply replicate traditional documents and spreadsheets, Cognition takes a structured data approach combining risk with test and requirements data so you can easily build relevant connections between data items, automatically create complex trace matrices, and export formatted documents instantly.
Get real-time traceability.
Providing a 360-degree view of your project.
With real-time and historical views of risks, requirements, and tests for the most informed planning, development, and impact analysis.
Change once, update everywhere.
Create a single point of truth.
For every data item – if a requirement is changed in the product requirements document for example, it is automatically updated throughout – ensuring data integrity.
See the impact of design changes.
Reduce the likelihood of information inconsistencies.
With fully traced data items, impact analysis becomes second nature. The effect of changes on upstream and downstream data connections can be easily viewed before making a change.
Reduce your data administration burden while increasing the quality of your product.
Cognition’s platform helps you manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.
Why Companies Rely on Cognition
Connected design controls are easy with Cognition.
Don’t let errors in design documentation hold back your regulatory approvals.
Modernizing the Approach to Risk Analysis in Medical Device Development
The limitations of spreadsheet-based analyses are becoming increasingly evident
Digital Transformation: A Global Shift in Data Management
Managing medical device product development data in Excel or Word is no longer enough
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Create products with compliance at the forefront of design.