Cognition Announces Compass MED 3.0, Bringing Automated Impact Assessment and Connected Testing to Medical Device Development

Impact assessed. Tests traced. Engineering connected. Giving medical device teams one compliant source of truth.

LEXINGTON, Mass., Nov. 9, 2026 /PRNewswire/ -- Cognition^® Corporation, a leader in SaaS-based product development solutions for life sciences, today announced the release of Compass^® MED 3.0, the most significant upgrade to its design control and risk management platform for medical device developers. Compass MED 3.0 addresses the areas where the Design and Development File (DDF) most often breaks down.

The release introduces automatic impact assessment with suspect link detection, an enhanced test management module, tag-based project variants, defect lifecycle tracking, and bi-directional connectors to Azure DevOps and Jira. Every change, test, and sync event is captured in an immutable audit trail.

"With Compass MED 3.0, teams no longer have to choose between engineering speed and rigorous design control documentation; they can do both concurrently," said Ben Higgitt, Compass MED Product Manager at Cognition Corporation. 

Key Enhancements in Compass MED 3.0

Automated Impact Assessment

Compass MED 3.0 accelerates change management in the Design and Development File by automatically triggering an impact assessment when a controlled item changes and flagging every suspect link, along with its wider upstream and downstream context. An approval gate holds unresolved impacts until they are assessed and closed with an electronic signature. Tracked action items take each issue through to closure. Side-by-side diffs, in-context suspect indicators, filters, and notifications show teams exactly what changed and what it affects. Role-based workflows and access control, dashboards, reporting, and an immutable audit trail make every decision defensible.

Enhanced Test and Defect Management

The enhanced test management functionality helps V&V teams work faster through flexible test campaigns. Test plans define which protocols run, which requirements they verify, and who is qualified to execute them, while test campaigns keep the resulting data organized. Teams capture deviations and defects during execution, reuse libraries across projects, and approve execution records with electronic signatures designed to support 21 CFR Part 11 compliance. The system includes built-in traceability reports, live dashboards, and test reports, and legacy test data from prior Compass MED versions carries forward.

"During our evaluation of Compass MED, what impressed me was how well the software supports best practices for risk management, human factors, and design controls. It's clear that Cognition has really invested in making the software fit the needs of medical device companies," said Aaron Joseph, Principal Consultant at Sunstone Pilot. 

Tag-Based Project Variants

Compass MED 3.0 lets teams save time and effort managing complex System and Subsystem development programs, especially with geographical or new technology iterations. Instead of starting from scratch or copying an entire project, teams select only the content they need using tags and quickly stand up a new variant. Reused data maintains traceability back to its source, and teams can manually sync one or more changes in either direction as the source and new projects evolve. The result is faster project creation without sacrificing traceability or control. 

Azure DevOps and Jira Connectors

Compass MED 3.0 pushes and pulls data to and from Azure DevOps and Jira on a schedule, on an event, or on demand. Synced data includes requirements, test cases, protocols, results, and defects. Compass MED audits every change and sync event through the integration, so software teams keep their tools and quality teams keep their evidence.

Next Steps with Compass MED 3.0

Compass MED 3.0 extends Cognition Corporation's commitment to connected, compliant product development, helping cross-functional medical device teams move faster while staying audit-ready. For more information or to request a demo, visit www.cognition.us or contact compassmed@cognition.us.

About Cognition Corporation 

Cognition Corporation provides product development and compliance solutions for the life sciences. With purpose-built software for MedTech, Biopharma, and combination products, Cognition helps teams accelerate development, strengthen traceability, and streamline submissions—all through structured, guided data management. Learn more at www.cognition.us. 

Media Contact: 

Kristen Callahan
Director of Marketing
Cognition Corporation
781.253.3388
426575@email4pr.com 

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SOURCE Cognition Corporation