Cognition Introduces Compass® MED 3.0 for Medical Device Development

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

Compass® MED 3.0 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, ensuring that every decision is defensible.

One of the key enhancements in Compass® MED 3.0 is the automated impact assessment feature. This allows teams to accelerate change management in the DDF 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, with side-by-side diffs, in-context suspect indicators, filters, and notifications showing 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.

Another significant improvement is the enhanced test and defect management functionality. This 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.

Tag-based project variants also play a crucial role in Compass® MED 3.0. This feature 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.

The release also features bi-directional connectors to Azure DevOps and Jira, pushing and pulling data to and from these tools 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.

With Compass® MED 3.0, teams no longer have to choose between engineering speed and rigorous design control documentation; they can do both concurrently. This release extends Cognition Corporation's commitment to connected, compliant product development, helping cross-functional medical device teams move faster while staying audit-ready.