Many medical device companies work across multiple systems that create a siloed approach to quality management.
Some have a home-brewed CAPA approach, or a separate tool for design controls. Others are stuck in paper-based systems that clutter and complicate quality.
These approaches don't scale. And they slow down the release of the innovative, life-saving products your patients need.
Qualio replaces your legacy systems with a centralized, cloud-based single source of truth that's accessible from anywhere.
Flexible workflows and templates give you room to mature and scale your quality processes with your business.
And design controls, documents, training and more are all handled in a consistent way - all underpinned by powerful reporting and audit trailing for complete visibility.
Learn how Qualio arms your business with a holistic, compliant medical device eQMS - from design controls to document management
A medical device quality plan is not only required by the FDA and ISO 13485, it can help you build robust and automatic quality into your product, processes and procedures. Here's how.
Learn how ArcScan manages, maintains and continuously improves the quality of its ultrasonic eye imaging devices using our software.
Qualio Design Controls is purpose-built to empower medical device and SaMD teams with complete mastery and visibility of their design control processes, from user needs to V&V.