Compass Solution Suite (MED/BIO/PRO) vs. Aligned Element

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.

The Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle.