Qualio launches Design Controls

The product will help medical devices companies launch and scale life-saving products

Qualio, the cloud quality management system software for the entire life sciences ecosystem, announced Design Controls for medical devices and software as a medical device (SaMD) companies. Design Controls, a new product within Qualio’s established electronic quality management software (eQMS), helps medical device companies expedite time to market by seamlessly integrating product development and quality management in one workstream and automatically generating detailed documentation to support compliance and regulatory approvals.


Robert Fenton, Founder and CEO, Qualio, said, “With Design Controls from Qualio, medical device companies now have a single source of truth for collaboration and compliance between product development and quality management, enabling teams to build with quality and velocity.”

Qualio’s cloud quality management software supports life sciences organisations with technology and services that allow them to seamlessly manage critical quality processes across their entire supply chain. Today, innovative medical device companies — like Proscia, ArcScan, and Fifth Eye — are already partnering with Qualio to seamlessly manage product development and quality management.

Over the last year, Qualio has experienced growing customer demand. The company now has more than 250 customers across the globe, spanning the medical device, pharmaceutical, biotech, and contract service provider markets. 

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