Qualio announced general availability of Compliance Intelligence, a major new capability inside the Qualio Platform. The Qualio Platform unifies regulatory compliance, quality management, and product lifecycle into one auditable system, so teams stay continuously audit-ready with less effort. Compliance Intelligence extends the platform with intelligent data-to-requirement mapping and gap detection, cross framework monitoring, a real-time compliance dashboard, built-in collaboration, and support for custom frameworks alongside FDA QMSR, ISO 13485, ISO 9001, ISO 27001 and MDSAP.

Regulatory expectations are tightening. FDA's Quality Management System Regulation (QMSR), which aligns Part 820 with ISO 13485, becomes effective on February 2, 2026, raising the bar for medical device quality systems. In Canada, the MDSAP has been mandatory for Class II–IV device manufacturers since January 1, 2019, making multi-market alignment operationally critical.

The oversight is real: in FY2024, FDA issued 47 medical device warning letters, 27 tied to Quality System Regulation requirements—evidence that quality and compliance remain under scrutiny. Independent industry analyses estimate recall costs can range from $10–$100M for pharmaceuticals, and some warranty or recall processes can reach $600M when all impacts are considered.

In parallel, modern life sciences companies are becoming increasingly software- and AI-driven, requiring more agile processes and greater deployment velocity, incompatible with manual document-driven compliance.