AI-powered gap analysis, continuous compliance monitoring, real-time visibility, and pre-built life sciences frameworks help organizations reduce audit preparation from months to days, accelerate market entry, and avoid costly compliance
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.
A shifting regulatory landscape demands a new class of platform
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 close 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.
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How Compliance Intelligence enhances the Qualio Platform
The Qualio Platform centralizes requirements, evidence, and actions across quality, regulatory and R&D functions. Compliance Intelligence enables the transition from point-in-time, document-centric, reactive compliance practices to data-centric, realtime audit-readiness. This is enhanced by the platform’s always-on capability that monitors the regulatory requirements mapped to the latest evidence and changes in connected systems, automatically flags gaps as things change, and gives leaders a unified dashboard to prioritize and track closure. The result is fewer surprises, shorter audit cycles, and a stronger compliance posture for lean teams.
GA capabilities available today
- AI-powered gap analysis that scans your entire QMS and connected data sources, maps evidence to regulatory requirements, and identifies gaps in minutes, not weeks
- Continuous compliance monitoring with real-time alerts when changes affect your compliance status
- Executive dashboard providing instant visibility into regulatory compliance & audit readiness across all frameworks
- Guided remediation workflows to assign gaps, track progress, and maintain audit trails
- Pre-built life sciences frameworks (such as FDA QMSR, ISO 13485, ISO 27001, MDSAP) plus custom frameworks for internal standards
Customer outcomes
“Compliance Intelligence gives us a 360-degree view of our audit readiness and automatically surfaces the gaps. We resolve issues faster, our team is more productive, and our risk is lower. With the system analyzing our documents and evidence end to end, we know we have full coverage and can walk into audits with confidence,” said Christophe Dohr, Site Quality Manager at Swiss medical device manufacturer Sentec.
Source: PRNewswire
