Compass

Compass is a Software-as-a-Service solution which guides and automates the design control process for medical product development. Purpose built to handle large quantities of data, Compass places compliancy at the core of product development. Compass supports compliance with ISO 14971 through integrated risk, design, and test management, enables real-time assessment of cause and effect into the impact of a change in the design process. In addition, Compass's design controls are built to follow a rigorous process in supporting compliance with 21 CFR 820.30. Trace metrics created by Compass provide a confirmation that all data inputs align with outputs, delineating clear connections among risk, design, and test components. Compass uses a risk-based approach to valid...