Qualio — a cloud quality management system software for the entire life sciences ecosystem — has announced Design Controls for medical device and software as a medical device (SaMD) companies. 

Design Controls, a new product within Qualio’s electronic quality management software (eQMS), helps medical device companies expedite time to market by integrating product development and quality management in one work stream and automatically generating detailed documentation to support compliance and regulatory approvals.

Robert Fenton, founder and CEO of Qualio, said: “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. 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 manage critical quality processes across their entire supply chain. 

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. 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.

Kevin Harris, president, CureMetrix, said: “Qualio’s Design Controls feature has been an important element of our product development and regulatory approval processes. 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 organise product development and quality management of a new test they plan to release this autumn.