Compass PRO

Compass® PRO is a SaaS suite of applications designed for risk assessment and management of combination products — medical products that integrate both device and drug components. It is built for device and drug product teams that need a unified framework to address how device and drug components interact and what risks may emerge from those interactions. Compass PRO combines the capabilities of Compass MED and Compass BIO into a single, dedicated platform.

Because combination products function as integrated systems, Compass PRO provides full visibility into device risks, drug risks, and interaction risks within one framework, supporting regulatory alignment and submission readiness throughout the product lifecycle.

Risk Management Capabilities

• Provides a unified framework that covers device, drug, and interaction risks together, so that no risk category is assessed in isolation.
• Highlights gaps in risk analysis to support regulatory alignment at each stage of development.
• Maintains consistent, traceable data throughout the product lifecycle.
• Supports post-market compliance by allowing updates to be made once, with changes automatically cascading across all impacted areas via "Where Used" visibility.

Workflow and Efficiency Features

• Offers guided steps, templates, and structured instructions for every phase of risk analysis.
• Allows teams to reuse pre-approved content from centralized libraries to improve consistency and reduce assessment time.
• Provides "change once, update everywhere" functionality to eliminate repetitive manual updates.
• Auto-generates submission-ready documents formatted to match existing SOPs.
• Removes reliance on Word documents and spreadsheets for risk management workflows.

Reporting and Documentation

• Auto-generates Risk Management Reports using live data, drawing from centralized inputs to support accuracy and completeness.
• Eliminates the need for manual consultation when compiling reports.
• Produces documents that align with submission requirements.

Data Management and Collaboration

• Aggregates data and documentation in a centralized repository accessible across various locations and teams.
• Stores links, decisions, annotations, and reviews in a unified system with complete historical data to reduce the risk of information loss.
• Supports cross-team collaboration by maintaining a shared record of risk management activity.
• Provides conditional filtering capabilities to locate specific information within extensive risk tables.

Compass PRO is delivered as a SaaS solution with quick implementation and customization options designed to fit into existing team workflows. The platform is developed by Cognition Corporation, and has been adopted by organizations including Smith & Nephew, whose IT R&D leadership noted simpler implementations, faster benefits, and improved risk management outcomes.