Enhance Medical Device Compliance

Cognition for Quality, Regulatory, and Compliance

Reduce risks, streamline processes, and accelerate submissions

Quality, Regulatory, and Compliance Management – Simplified.

Delayed submissions, failed submissions, and subsequent audits disrupt company operations, significantly impacting revenue.

Our design control software—specifically created for medical device manufacturers—streamlines regulatory and compliance management while enhancing data integrity, so that you reach the submission phase sooner and are assured of audit readiness.

What You’ll Experience

Far too many quality, regulatory, and compliance leaders are hindered by disconnected data, manual traces, and documentation errors. We provide automated trace matrices and guided templates to ensure compliance.

Plus, you’ll save time with submission-and audit-ready reports that you can export instantly in the required formats.

Guided workflows for compliance with ISO 14971, ISO 13485, and 21CFR820.30
Built-in templates for risk management planning, preliminary hazards analysis, use error analysis, FMEA, and product risk analysis
Central library of harms and hazards, referenced across projects to ensure consistency
Submission-ready reports can be exported instantly in the required formats (ensuring consistency between internal data and exported documents)
Automated trace matrices across even the most complex projects
Out-of-the-box and configurable risk management processes specifically for medical device design and development
Enhanced data integrity with tightly integrated risk management, requirements management, and test management
Easy imports of data/documentation from Word, Excel, or other domains
Seamless integration with other systems to ensure appropriate data/document linkages
Embed global and/or regional regulations and standards, and easily adapt to regulatory changes
Design review and approval cycles with electronic signatures with user/admin privileges

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Key Benefits

Manage Risk – At Every Level

Tightly integrate risk with requirements and tests to ensure data consistency throughout all phases—enabling you to deliver more compliant products to market.

File Documents Faster

With integrated risk management, requirements management, and test management, you can start compiling what’s needed for regulatory approval sooner—speeding your time to submission.

Be Audit Ready

Automatically generate and export master trace matrices and documents for the design history file, technical documentation records, audits, and more—in the formats required by regulatory bodies.

See Cognition in Action

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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Learn what streamlined quality, risk, and compliance management can do for your company.

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Helpful Resources

Why Many Medical Device Companies Are In Danger of Risk Analysis Missteps

Cultivating Risk-Focused Design Instincts