Bring Safer Products to Market, Faster
Accelerate design control with a solution specifically engineered for life science manufacturers
Enhance Development – At Every Step
It’s never been both more challenging and more important to bring medical devices to market faster. Our design control solution can help. With real-time traceability, guided design controls, change once, update everywhere functionality, submission-ready documents, and more—we’ll increase your efficiency while ensuring data integrity and compliance.
Trusted By
Bring Cross Functional-Teams Together
A manual approach to product design—relying on Excel, Word, or paper—elongates processes and increases the risk of errors. We provide an information-driven approach with both an intelligent document-centric and data-centric workspace across every functional area.
With more connected and consistent information, you’ll save time and resources while enhancing collaboration and enhancing risk management.
Maximize Efficiency
We automate, integrate, and enhance processes across requirements management, risk management, and test management, so that you can reduce manual data entry, easily build connections between items, and automatically create complex trace matrices.
With all your data in one system, you’ll gain a 360-degree view of your progress, as well as real-time and historical views of risks, all levels and types of requirements, tests, and more.
Streamline Submissions and Audits
With integrated requirements, risk, and test management, you can start compiling, in parallel, what’s needed for regulatory approvals sooner—speeding your time to submission. Further accelerate your processes with submission- and audit-ready reports that can be exported instantly.
Plus, with guided templates to ensure compliance with ISO 14971, ISO 13485, and 21CFR820.30—you’ll gain more regulatory approvals upon first submission.
5
OF THE TOP 6 MEDICAL DEVICE COMPANIES USE COGNITION
275K+
PRODUCTS SUPPORTED
ISO 14971 & ISO 13485
SUPPORTED STANDARDS
Everyone Benefits
R&D & Systems Engineering
Drive innovation with the highest possible quality
Quality, Regulatory, & Compliance
Reduce risks, streamline processes, and accelerate submissions
Project Management
Reach critical milestones sooner
Leadership
Get to market faster
Speed to Market – Within Reach
With more than 20 years in the industry, deep experience informs everything we do. We provide both out-of-the box and highly configurable workflows to ensure our solution complements and enhances your current processes, at every turn.
- Integrated requirements, risk, and test management
- Guided compliance templates
- Automated trace matrices
- Change once, update everywhere capabilities
- Built-in and configurable workflows for authoring, reviewing, and releasing information
- Instant exports of submission-ready documents
- Reusable documents, data, and test methods
- Import data from/integrate with other systems
- Structured implementation and training
- Data-centric workspace tables and document-centric formats
What Customers Say
Ready to Move Faster?
Learn why the leading life science companies are leaving Excel, Word, and other design control solutions in the past.