Get your medical device to market faster with integrated design control software

Pull your device design data together and stamp out risks with specialized medical device design software. Focus on building a great medical device - without the headache of manual compliance work.

Streamline your device development with design controls management software

Challenge

Quality teams work in one system. Engineering teams in another. Siloed and disconnected teams and platforms make traceable, compliant product development impossible to manage. Work grinds to a halt, quality and development work against each other, and your path to market becomes a complex nightmare.

Solution

Qualio's design control software offers a single source of truth for all your product development activities. Pull product data into Qualio with integrations. Control inputs, requirements and risks. Bring your quality and engineering teams into sync. All underpinned by a complete, compliant document stack to show your auditors.

Unite systems and data to enable effective collaboration and stop delays

• Demolish quality and engineering siloes by connecting systems like Jira, Azure DevOps and TestRail to a centralized, compliant medical device design software platform
• Build a real-time, always-up-to-date document stack that flows seamlessly from your engineering team to quality 
• Centralize all design control data by product, from custom categories and components to requirements, inputs, outputs, risks and drag-and-drop attachments

Maintain end-to-end traceability across systems in real time

• Stay totally compliant at all times with automated prompt icons that draw your attention to where it's needed, from missing connections and unresolved risks to outdated test results
• Drive changes and product updates quickly and easily
• Use the Traceability tab for a bird's-eye view of your design elements while your engineering teams work in the source systems they know and love

Generate release documentation with one click

• Easily produce quality documentation to ensure you’re delivering a safe and effective product, eliminating time-consuming paper-based processes and manual governance
• Be 100% audit-ready at all times with documentation, e-signatures and objective evidence
• Access automated snapshots of product documentation, like a Change History Report, for each stage of your product lifecycle

Design control software purpose-built for your quality and product teams

Quality teams…

… for medical device, SaMD and SiMD companies enjoy a single source of truth for design controls and product data. Export automated documentation, embed FMEA and ISO 14971 risk management and unlock complete traceability from input to output.

Product teams…

…enjoy uninterrupted development as the engineering systems they're used to are linked directly to audit-ready design controls management software. Develop and innovate, safe in the knowledge that your work is flowing accurately and in real time straight to the quality department.