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Cognition for Executives and Strategic Leaders

Get to market faster and reduce development costs by maximizing efficiencies

Accelerate Design and Development with a Streamlined Solution

When it comes to medical device development, the opportunities are endless. At the same time, the pressure to innovate quickly is extraordinary. 

Our design control solution—specifically built for medical device manufacturers—will speed your time to market, without sacrificing safety or quality.

Unleash New Possibilities

With more than 20 years serving medical device companies, deep experience informs everything we do. Our solution is specifically designed to enhance efficiencies, improve data integrity, and ensure compliance. 

Key features include:

  • Integrated requirements management, risk management, and test management
  • Automated trace matrices 
  • Guided compliance templates 
  • Instant exports of submission-ready documents
  • Reusable documents, data, and test methods across projects
  • Change once, update everywhere capabilities 
  • Structured implementation and training to ensure ongoing success

Transition with Ease

We partner with you, at every step.

  • We provide both out-of-the-box and highly configurable workflows—both to industry-wide best practices and to your company’s procedures 
  • We make it easy to import data and integrate seamlessly with your current systems 
  • We provide a dedicated customer success partner to provide you with ongoing support, whenever you need it
  • We make it easy to scale up incrementally, based on your timeline and needs (start with one project, then expand as needed)

Key Benefits

Maximize Efficiency and Collaboration

Automate, integrate, and enhance processes across requirements management, risk management, and test management to improve efficiencies and enhance data integrity.

Reduce Risks and Ensure Compliance

Use guided templates to ensure compliance with ISO 14971, ISO 13485, and 21CFR820.30 and get to market faster with submission-ready documents that can be exported instantly.  

Make More Informed Decisions

Gain a 360-degree view of your projects to easily monitor and assess progress—at every phase of design and development.

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What Our Customers Say

Our risk module from Cognition enables us to effectively manage risk. The ‘plug’ nature of the risk module means we have simpler implementations with faster benefits. Ultimately, we are saving time and seeing better risk management.”

– 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.”

– Miklos 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.”

– Chris Henry, Senior Manager, Software Quality and 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.”

– Shaun Cronin, PLM Associate Director, Zimmer Biomet

Featured Case Studies

Learn how our design control solution is helping other R&D leaders maximize efficiencies, save resources, and enhance data integrity. 

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Ready to Get to Market Faster with Cognition?

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Helpful Resources

How to Speed Time to Market: Emerging Challenges and Acceleration Opportunities

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How to Identify an Effective Medical Device Design Control Software Platform

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