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.

See Cognition in Action




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


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

Learn More About How We Can Help

What Customers Say

“Our New Risk Module for Cockpit Enterprise enables us to effectively manage risk.  The “plug-in” nature of the new risk module means we will have simpler implementations with faster benefits. Ultimately, we are saving time and seeing better risk management.”
Placeholder Image
Ian Bennett, IT R&D Leader, Smith & Nephew
“With Cognition, we instantly gained access to document templates, workflows, and a knowledge base, which guided us to perform our processes in better compliance with critical standards and good engineering practices.”
Placeholder Image
Miklós Czeller, R&D Director, Mediso
“Cognition’s solution ensures teams spend significantly more time focused on productive work, rather than building and maintaining documents and complex traces. This allows us to run lean and still accelerate our time to market.”
Placeholder Image
Chris Henry, Senior Manager, Software Quality Engineering, Epic Sciences
“Before Cognition we were manually creating data and data connections that were maintained in paper DHFs that were difficult to scale. Now we are able to create the same data and links in a way that allows Zimmer Biomet to easily maintain large trace matrices.”
Placeholder Image
Shaun Cronin, PLM Associate Director, Zimmer Biomet

Request a Demo

Webinar - How to Speed Time to Market, Safely: A Panel Discussion with Medical Device Manufacturers | Wednesday, July 31, 2024 | 12:00PM EST