Qualio introduces Design Controls, a new product to help medical device companies launch and scale life-saving products

SAN FRANCISCO, August 25, 2021 / PRNewswire / – Building on their recent Series B announcement, Qualio – the trusted cloud quality management software for the entire life sciences ecosystem – announced today Design checks for medical device and software as medical device (SaMD) companies. Design Controls, a new product within Qualio’s electronic quality management software (eQMS), helps medical device companies accelerate time to market by seamlessly integrating product development and quality management into a workflow and automatically generating detailed documentation to support compliance and regulatory approvals.

“For too long, medical device companies have suffered from the impacts of siled teams and manual processes that make traceability and compliant versions nearly impossible to manage,” said Robert fenton, founder and CEO of Qualio. “With Qualio’s design controls, medical device companies now have a single source of collaboration and compliance between product development and quality management, enabling teams to build with quality and speed. ”

Qualio’s cloud-based quality management software supports life science organizations with technologies and services that enable them to transparently manage critical quality processes across their supply chain. Today, innovative medical device companies, such as Proscia, ArcScan and Fifth Eye, are already partnering with Qualio to transparently manage product development and quality management.

Design Controls is based on Qualio’s current quality management system by:

  • Unite systems and data to enable efficient collaboration and reduce delays in product development – Design checks eliminate silos between quality and engineering teams by delivering product information from Jira, Azure DevOps and TestRail directly to Qualio, creating a single source of truth for product development.
  • Maintain end-to-end traceability between systems in real time – Deficiencies in design controls are one of the main reasons for FDA citations. With Qualio’s design controls, teams can maintain compliance by accessing design documentation in one place, managing ISO 14971 and FMEA changes and risks across all systems, and approving with compliant signatures. part 11.
  • One-click release documentation generation – Qualio’s design checks automatically compile your artifacts into key documents such as risk analysis and requirements traceability matrices, eliminating manual filing and tedious spreadsheets, and ensuring teams deliver product safe and effective in the market with confidence and speed.

“Qualio’s design control function has been an important part of our product development and regulatory approval processes,” said Kevin harris, President, CureMetrix. “We provide an AI-based medical device that examines mammograms and detects abnormalities. Quality and speed are essential because we know that delays on our end impact the lives of real people. The company leveraged Qualio’s Design Controls feature to organize product development and quality management for a new test that it plans to launch this fall.

Over the past year, Qualio has seen increasing customer demand. The company now has more than 250 customers around the world, spanning the medical device, pharmaceutical, biotechnology and contract service provider markets. For more information on how Qualio can help streamline and protect quality management and accelerate the delivery of safe and effective medical devices, visit Qualio.com.

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

Qualio’s completely remote global team takes pride in 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, Where Twitter.


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