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 lets you easily unite teams, processes, and data so your organization can get products to market quickly and scale successfully.
With Qualio, your organization can grow through all 12 pillars of quality as you scale including premarket activities, registration, and regulatory compliance while in market.
- Document Control
- Training
- Design Controls
- Supplier QA
- Risk Management
- Complaint Handling and Feedback
- Corrective and Preventive Action (CAPA)
- Change Control
- Non-Conformance Reporting (NCR) and Deviation
- Internal Audit
- Management Review
- Equipment Management and Calibration
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.
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.
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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