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.
Qualio Design Controls 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.
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.
enjoy uninterrupted development as the engineering systems they're used to are linked directly to Qualio.
Develop and innovate, safe in the knowledge that your work is flowing accurately and in real time straight to the quality department.
Become a design controls expert and start applying the 9 core elements of medical device design controls with our comprehensive breakdown guide.
Make paper, filing cabinets, folders and spreadsheets a thing of the past.
Detect and mitigate risks and comply with
ISO 14971 and ICH Q9.
Control and categorize suppliers and third parties with complete visibility.
Build a competent, confident, compliant, continuously improving workforce.
Manage change activity easily and effectively with complete traceability.
Make compliance and audit readiness the natural core of your business DNA.
Build automated response workflows for any quality event.