From Software Release Bottlenecks to Automated Velocity: SafeBeat’s Journey with Ultralight

With Ultralight, SafeBeat discovered an opportunity to modernize their quality management system, unify their engineering and quality processes, and accelerate their product development cycles.

SafeBeat: Dedicated to improving cardiac care outcomes

SafeBeat®, a pioneering cardiac care software-as-a-medical device (SaMD) startup, recognized the need for modern tools to streamline their product development and quality management processes. The existing vendor landscape lacked solutions that could effectively integrate engineering and quality workflows while maintaining the necessary controls for SaMD development.

The Challenge: Standardized data collection across 30 study sites

The Solution: Ultralight by Greenlight Guru

SafeBeat selected Ultralight for its comprehensive SaMD-focused product and compliance hub, which promised to address their specific needs:

• Modern and flexible QMS. Ultralight offers an intuitive interface configurable workflows that allow quality teams to work seamlessly.

• Automated traceability. Ultralight's system automatically maintained traceability between requirements, code, and test results.

• Integrated development environment. Ultralight's seamless integration with GitHub allowed SafeBeat to manage their entire product lifecycle in one place, from requirements and design controls to risk management and testing.

• Automated test report evidence collection. The SafeBeat team is able to collect test evidence seamlessly with Ultralight's test reporting tools, and generate final documentation ready to be controlled.

  
  

The Results: Faster product cycles in a more collaborative environment

By leveraging Ultralight's modern, SaMD-focused quality management system, SafeBeat has positioned itself to deliver innovative cardiac technologies to patients faster and more efficiently. This partnership demonstrates how SaMD companies can benefit from adopting integrated, code-centric quality management solutions to accelerate their product development while maintaining the highest standards of safety, efficacy, and regulatory compliance.

• Accelerated product cycles. The integrated platform allowed SafeBeat to iterate and release updates to their Al algorithms and software platforms more rapidly, speeding product cycles by 25%.

• Drift prevention. Documentation in code prevents the drift between code and test procedures by tying them together.

• Reduced manual documentation time. Automation of documentation processes saved dozens of hours each month, freeing up valuable time for core product development and innovation.

• Enhanced collaboration. The unified platform fostered better communication between engineering and quality assurance teams, leading to more efficient problem-solving.

• Maintained regulatory compliance. Ultralight enabled SafeBeat to maintain rigorous quality standard by integrating quality intro the engineering workflow.