Qualio

Qualio is a cloud-based Quality Management System (QMS) that helps regulated life sciences, medtech, biotech, and pharma companies manage quality, design controls, and compliance. It combines QMS, design-controls workflows and compliance intelligence to keep teams continuously audit-ready and automates gap analyses across 28+ regulatory standards (FDA, ISO 13485, MDR, etc.), cutting audit prep from 20+ weeks to under 4. Qualio includes document control, training, CAPA, supplier management and reporting to help teams scale development while maintaining regulatory compliance.