SaMD Quality Software

Qualio offers an electronic Quality Management System (eQMS) specifically designed for organizations developing software as a medical device (SaMD). It facilitates faster product development without compromising on quality by uniting engineering and quality teams in a single collaborative environment. This integration helps maintain compliance with IEC, ISO, and FDA regulations.

For SaMD teams, balancing speed and quality can be challenging due to separate systems for engineering and quality. Qualio addresses this by providing a unified platform that simplifies managing traceability, auditability, and compliance, thus expediting the market entry of SaMD products without sacrificing oversight and quality.

Key Features

• Integration with systems like Jira, Azure DevOps, and TestRail for enhanced collaboration.
• API connectivity to centralize product design data.
• Guided workflows for document drafting, reviewing, approving, and retiring.
• One-click generation of key release documentation such as requirements traceability and risk analysis matrices.
• Role-based training assignments with in-line capabilities.

Benefits

• Facilitates robust closed-loop quality management with end-to-end traceability across design and development tools.
• Enables detailed analysis of product lifecycle data to address risks and demonstrate control to auditors.
• Supports periodic review cadences to meet FDA, IEC, and ISO standards.

Qualio is praised for its ease of use, quick onboarding, and ability to keep organizations audit-ready. It supports scalable growth and seamless compliance with standards like ISO 13485:2016, ensuring that changes are globally applied across the quality management system.