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# Compass Solution Suite (MED/BIO/PRO) Discussions

Medical device and biopharma teams don't get a second chance at patient safety. Our Compass Solution Suite (MED/BIO/PRO) were built for that reality — a unified risk and usability management platform that helps regulated teams identify, document, and control risk across the full product lifecycle. Instead of stitching together spreadsheets, disconnected tools, and manual audit trails, Compass gives teams one system of record for usability engineering, criticality analysis, and combination product risk management — built to hold up under FDA and notified body scrutiny. Three solutions, one platform: Compass MED Compass MED is purpose-built for medical device usability and compliance. It helps device manufacturers run structured Human Factors Engineering and Usability Engineering programs aligned to IEC 62366-1 — from use-related risk analysis through formative and summative evaluation. Teams get a defensible, audit-ready record of every use error, mitigation, and design control decision, replacing scattered documentation with one traceable system built for regulatory submission. Compass BIO Compass BIO brings structure and speed to biopharma criticality analysis. It helps process development and quality teams assess and rank critical quality attributes (CQAs) and critical process parameters (CPPs) with a consistent, defensible methodology — supporting Quality by Design (QbD) programs and regulatory filings. Compass BIO replaces ad hoc risk ranking exercises with a repeatable, auditable framework the whole team can stand behind. Compass PRO Compass PRO is built for the unique complexity of combination products — where device, drug, and biologic risk frameworks have to work together, not against each other. It unifies usability engineering and criticality analysis into a single risk management approach, giving combination product teams one consistent, traceable framework instead of forcing device-side and drug-side risk processes into separate silos.

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