Design Controls

Qualio's Design Controls is a purpose-built medical device design control software that brings quality and engineering teams together on a single, compliant platform. Designed for medical device, SaMD, and SiMD companies, it eliminates the silos and disconnected systems that slow product development, replacing manual compliance work with an integrated, audit-ready environment that accelerates the path to market.

The core challenge Qualio addresses is the disconnect between quality teams and engineering teams working in separate systems. By providing a unified source of truth for all product development activities, Qualio's design control software synchronises teams, centralises data, and ensures traceable, compliant development from input to output — without grinding workflows to a halt.

Uniting Systems and Enabling Collaboration

• Connects directly with engineering tools such as Jira, Azure DevOps, and TestRail, demolishing the silos between quality and engineering departments
• Builds a real-time, always-up-to-date document stack that flows seamlessly from engineering to quality
• Centralises all design control data by product, including custom categories, components, requirements, inputs, outputs, risks, and drag-and-drop attachments

End-to-End Traceability Across Systems

• Maintains continuous compliance with automated prompt icons that highlight missing connections, unresolved risks, and outdated test results
• Enables fast, easy product changes and updates while keeping traceability intact
• Provides a dedicated Traceability tab offering a bird's-eye view of all design elements, while engineering teams continue working in their preferred source systems

One-Click Release Documentation

• Generates quality documentation with a single click, eliminating time-consuming paper-based processes and manual governance
• Ensures 100% audit readiness at all times through documentation, e-signatures, and objective evidence
• Delivers automated snapshots of product documentation — such as Change History Reports — for each stage of the product lifecycle

Purpose-Built for Quality and Product Teams

• Quality teams at medical device, SaMD, and SiMD companies benefit from a single source of truth for design controls and product data, with automated documentation export, embedded FMEA and ISO 14971 risk management, and complete input-to-output traceability
• Product and engineering teams enjoy uninterrupted development, with their familiar engineering systems linked directly to audit-ready design controls management software, ensuring work flows accurately and in real time to the quality department

Compliance and Standards Support

• Meets ISO and FDA requirements for medical device design controls
• Embeds ISO 14971 risk management and FMEA directly within the design control workflow
• Supports 510(k) submissions, ISO 13485 certification, and MDSAP audit readiness

Qualio Design Controls is delivered as a cloud-based solution and forms part of Qualio's broader Quality Management System (QMS) platform, which also includes document management, risk management, supplier management, training management, change control, audit management, CAPA and NCR management, and compliance management — providing a comprehensive, integrated quality infrastructure for life sciences companies.