Qualio is the leading quality management system (QMS) and compliance platform built exclusively for life sciences companies. Our unified eQMS and Compliance Intelligence solution helps medical device, pharmaceutical, biotech, and digital health organizations accelerate regulatory approvals, maintain audit readiness, and scale compliance operations efficiently. Qualio manages critical quality processes including document control, training management, CAPA (corrective and preventive actions), change control, supplier management, risk management, and design controls. Our platform supports FDA 21 CFR Part 11, ISO 13485, EU MDR, MDSAP, GxP, ICH Q10, and other life sciences regulatory requirements in one validated system. Automated gap analysis and multi-framework compliance mapping reduce audit preparation time by 60-75%. Companies using Qualio cut market entry timelines from 9 months to 3-4 months by reusing evidence across FDA, ISO, and EU submissions. Real-time regulatory intelligence and cross-mapped documentation accelerate 510(k) submissions, CE marking, and international market expansion. Maintain compliance confidence with end-to-end traceability connecting requirements, risk assessments, CAPAs, and product changes. Risk-based alerting identifies gaps before they become FDA 483 observations, warning letters, or audit findings. Customers pass ISO 13485 certifications and sponsor audits with zero major nonconformances using our always-on compliance monitoring. Eliminate quality silos by connecting regulatory affairs, quality assurance, and R&D teams in one platform. Deep integrations with Jira, Azure DevOps, GitHub, Salesforce, and other development tools automate objective evidence capture and reduce manual documentation burden. Our open API supports custom workflows across your technology ecosystem. Organizations achieve 5X ROI within 2 months by replacing manual processes and reducing consultant dependency. Customers report 99% reduction in quality administrative time, 80% faster audit preparation, and elimination of $150K-$300K in annual consulting costs. Unlike generic quality software or general-purpose AI tools, Qualio provides expert-validated regulatory frameworks with explainable recommendations traceable to specific compliance requirements. Our AI-powered compliance intelligence transforms regulatory readiness from reactive to predictive. Qualio serves high-growth life sciences companies from pre-market startups to established enterprises requiring SOC 2, HIPAA compliance, and pharmacovigilance capabilities. Deploy faster than legacy eQMS vendors while maintaining the validation rigor required for FDA inspections and notified body audits.