###### DESIGN CONTROLS # Full traceability from requirements to release #### Link requirements to verification to validation in one connected system. Risk matrix, design outputs, and DHF generation with a complete audit trail. ## 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. ### 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automated prompt icons that draw your attention to where it's needed, from missing connections and unresolved risks to outdated test results - Drive changes and product updates quickly and easily - Use the Traceability tab for a bird's-eye view of your design elements while your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. ## Design controls management resources #### Ultimate guide to medical device design controls Become a design controls expert and start applying the 9 core elements of medical device design controls with our comprehensive breakdown guide. [Get my guide](/content/resources/ultimate-guide-to-medical-device-design-controls/index.html) #### Design control software datasheet Learn how our medical device design software combines powerful functionality with ease of use for a controlled, compliant pathway to market that meets ISO and FDA requirements. [Get my datasheet](/content/resources/document-management-datasheet "Get my datasheet"/index.html) [Get my datasheet](/content/resources/design-controls-management-datasheet/index.html) ## See other features that make Qualio the #1 top-rated cloud QMS #### Document management Make paper, filing cabinets, folders and spreadsheets a thing of the past. [Learn more](/content/product/document-management-software/index.html) #### Risk management Detect and mitigate risks and comply with ISO 14971 and ICH Q9. [Learn more](/content/product/risk-management-software/index.html) #### Supplier management Control and categorize suppliers and third parties with complete visibility. [Learn more](/content/product/supplier-management-software/index.html) #### Training management Build a competent, confident, compliant, continuously improving workforce. [Learn more](/content/product/training-management-software/index.html) #### Change control management Manage change activity easily and effectively with complete traceability. [Learn more](/content/product/change-control-software/index.html) #### Audit management Make compliance and audit readiness the natural core of your business DNA. [Learn more](/content/product/audit-management-software/index.html) #### CAPA & NCR management Build automated response workflows for any quality event. [Learn more](/content/product/capa-management-software/index.html) #### Compliance management Get audit-ready in weeks, stay audit-ready forever. [Learn more](/content/compliance-management-software/index.html) ## Trusted by 500+ life sciences companies ### Hear from our customers ##### “We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing quality to one department, Qualio breaks down that barrier.” ###### Daniel A. ###### Chief Technology Officer, InVivo Bionics ##### "When you're using paper, you're not moving forward. You can't. ##### Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now. ##### I don't think that'd be possible if we didn't have Qualio." ###### Ami A. ###### Director of Ops & Quality Management, NeuFit ##### "I’ve never been more confident in my 27 years of being audited." ###### Lowell H. ###### Director of Quality Assurance, Restech ##### "Qualio is the best QMS cloud-based system I have ever seen." ###### Paul H. ###### Senior VP of Ops, Tech & Quality, Advantice Health ##### "You're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources. ##### That's unique in this industry." ###### Becki N. ###### Quality & Regulatory Lead, Synthego