The trusted Quality Management System Software
for Medical Devices

Product development with Qualio helps you meet design control requirements of ISO 13485 and FDA 820 regulations and provides a clear view of your development processes from needs to verifications to validations.



Qualio is built to make FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485 & 14971 audit-readiness a piece of cake. While your competitors are wrestling with regulatory bodies, you’ll zip through compliance and move to streamline systems for bigger profits.



Qualio is easy to use and provides the real-time feedback capabilities you need across a distributed workforce, accelerating your time to market. By generating revenue sooner, you’ll have more capital to grow more quickly than the other players in the market.



Qualio is flexible enough to grow with your team. That means you won’t have to replatform in the middle of the crucial startup and scale-up stages. While the other companies burn months moving from one rigid QMS to another, you’ll take a lead that will be hard to overcome.



Track every change and action from beginning to end with fully integrated, closed-loop quality processes. Keep all key stakeholders informed with Qualio’s powerful reporting capabilities.

Trusted by 100s of life sciences and healthcare
organizations all over the world.


Streamline Product Development

Reduce time-to-market by integrating quality and product development processes.

Bring devices to market quickly with design control and risk management features that integrate with your pre-production and post-production quality activities.

Capture drug development outputs and collate them together for seamless review and submission at each key step along the regulatory approval pathway.

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Control and Access Documents

Effortlessly create, review, approve and control documents and records. With Qualio’s secure, cloud-based system files, folders, and spreadsheets become a thing of the past.

Qualio’s template engine and simple web-editor make creating content a breeze, and guided workflows walk you through each step of document drafting, review, and approval.

Incorporates FDA CFR Part 11 compliant digital signatures.

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Assign and Capture Training

Integrated, role-specific training supports in-line assignments and tracking of all training activity within the quality platform.

Automated notifications and reporting provide full visibility into training gaps so they can be addressed to maintain quality standards and compliance.

Training assessments make it possible to go beyond "read and understand" training to capture competency.

Identify and Resolve Issues

Quickly capture quality events like non-conformances, deviations, customer complaints and much more. Track progress from creation, investigation, and root cause analysis, to CAPA, validation of successful outcomes and closure.

Assign CAPA-related tasks to your team and track progress through to completion.

See quality trends in real-time and take proactive resolution steps.

Capture customer feedback and complaints and link to CAPA and other quality follow-up activities.



Pass Audits and Drive growth

Qualio provides a single place to manage audits, suppliers, change management and understand what's happening across your entire business in real-time. You can’t do this with paper, hybrid or legacy systems that silo data from different systems.

Qualio is closed-loop quality like you’ve never seen it before.

Make decisions that drive your business forward, confident that you have all the information you need at your fingertips, and empower teams across your business to collaborate.

Consistently ranked as the quality management platform of choice by medical device manufacturers, therapeutics companies regulated contract service providers.



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