Qualio Introduces Design Controls, a New Product To Help Medical Device Companies Launch and Scale Life-Saving Products

Design Controls brings product development and quality management together in one simplified and traceable cloud-based quality management system

SAN FRANCISCO, August 25, 2021 –Building on their recent Series B announcement, Qualio — the trusted cloud quality management system software for the entire life sciences ecosystem — today announced Design Controls for medical device 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 work stream and automatically generating detailed documentation to support compliance and regulatory approvals.

“For too long, medical device companies have suffered from the impacts of siloed teams and manual processes that make traceability and compliant releases nearly impossible to manage,” said Robert Fenton, founder and CEO of Qualio. “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 organizations 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.

Design Controls builds on Qualio’s current purpose-built quality management system by:

  • Uniting systems and data to enable effective collaboration and reduce delays in product development – Design Controls eliminates silos between quality and engineering teams by streaming product information from Jira, Azure DevOps, and TestRail directly to Qualio, creating a single source of truth for product development.
  • Maintaining end-to-end traceability across systems in real time – Gaps in design controls are one of the top reasons for FDA citations. With Qualio’s Design Controls, teams can maintain compliance by accessing design documentation in one place, managing change and ISO 14971 and FMEA risks across systems, and approving with Part 11 compliant signatures.
  • Generating release documentation with one click – Qualio’s Design Controls automatically compiles your artifacts into key documents like Risk Analysis and Requirement Traceability Matrices, eliminating manual collation and tedious spreadsheets — and ensuring teams deliver a safe and effective product to market with confidence and speed.

“Qualio’s Design Controls feature has been an important element of our product development and regulatory approval processes,” said Kevin Harris, President, CureMetrix. “We provide an AI-based medical device that screens mammograms and detects anomalies. Quality and speed are critical because we know delays on our end impact real peoples’ lives.” The company has leveraged Qualio’s Design Controls feature to organize product development and quality management of a new test they plan to release this fall.

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. For more insight on how Qualio can help streamline and safeguard quality management and accelerate delivery of medical devices that are safe and effective, visit Qualio.com.

About Qualio
With more than 250 life sciences customers worldwide, Qualio is the most trusted quality management software for teams launching and scaling life-saving products. Leading pharmaceutical, biotech, medical device, and clinical research organizations leverage Qualio’s cloud-based quality management system software to unite their teams’ processes and data. Qualio enables customers to deliver on the promise of quality and meet the complex regulatory compliance requirements without sacrificing speed.

Qualio’s global, all-remote team prides itself on empowering customers to deliver effective, consistent, and safe products that improve all of our lives. For more information, please visit us at Qualio.com, LinkedIn, or Twitter.


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