Build at full speed. Your compliance record keeps up.
Qualio connects development work directly to your compliance record. Engineers keep building in their existing tools while requirements, design controls, and documentation stay up to date.
How it works
Qualio connects to the systems your engineers already use, keeps requirements and design controls traceable as work progresses, and generates the documentation your submission needs from that record.
Design controls and requirements traceability connect development work directly to your compliance record. When it's time to file, documentation comes from the same record your team has been maintaining all along. No reconciliation required.
Integrates with product development systems including Jira, GitHub, and Linear keeping your team compliant without slowing down time to market.
A live link between development work and the compliance record throughout the product lifecycle.
Approve a Design Review and Qualio generates the DHF documentation that depends on it: requirements specification, requirements trace matrix, test specification, and risk analysis.
Manage product development, quality, and regulatory work in one system. Fewer handoffs. Fewer gaps between teams.
“I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that.”
Head of Quality & GxP Compliance, 30 Technology
“Qualio's Design Controls feature has been an important element of our product development and regulatory approval processes. We provide an AI-based medical device that screens mammograms and detects anomalies. Quality and speed are critical because we know delays on our end impact real peoples' lives.”
President & Co-Founder, CureMetrix
“Qualio gives everyone a roadmap in this time when we're having to move very quickly. Having that structure for everyone to work within is going to be essential for us to really succeed.”
CEO, EvoEndo
“I don't think we would've been able to pull it off if we didn't have a partner that could provide us guidance and templates. There's just no way. It's not even a time saving. It's a go-no go situation.”
Head of Quality & Operational Excellence, ViQi
Qualio runs a system of action on a purpose-built compliance system of record, keeping context and action connected in one closed loop.
Outputs are auditable and defensible, with human approval and bounded autonomy on every agent action.
Connects regulatory frameworks, controls, evidence, and outcomes in a shared knowledge model that improves with time.
Get a demo and see how Qualio keeps compliance moving at the pace of your development team.
