From Software Release Bottlenecks to Automated Velocity: SafeBeat’s Journey with Ultralight
Accelerated Product Cycles
Reduced Manual Documentation Time
Drift Prevention
Enhanced Collaboration
Maintained Regulatory Compliance
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Partnering with Ultralight Labs has been a game-changer for SafeBeat. Their comprehensive SaMD-focused platform addresses our critical needs, offering a modern, flexible QMS and seamless integration with our development environment. Ultralight's automated traceability and test report evidence collection have dramatically improved our efficiency and ensured that compliance is built into our workflow. This partnership allows us to confidently manage our product lifecycle, from design controls to risk management, while maintaining the highest standards of quality and regulatory compliance.
Dr. Rachita Navara
Cofounder & CEO, SafeBeat
Introduction
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.
With Ultralight, SafeBeat discovered an opportunity to modernize their quality management system, unify their engineering and quality processes, and accelerate their product development cycles. Ultralight's solution provided automation for many previously manual tasks, enabling SafeBeat to dedicate more resources to their core mission of revolutionizing cardiac care through AI and remote patient monitoring.
A Bit About SafeBeat
SafeBeat was founded in 2021 by Dr. Rachita Navara, an EP cardiologist and engineer, and Dr. Kunj Patel, a physician and applied mathematician. SafeBeat specializes in going beyond diagnostics to support cardiac therapeutics. Their innovative platform expands access to remote patient monitoring, event monitoring, and software-enabled remote therapeutic monitoring. Based in San Francisco, their multidisciplinary team includes software engineers, data scientists, and quality assurance experts dedicated to improving cardiac care outcomes.
SafeBeat was recently awarded a $2M SBIR grant from the National Heart, Lung, and Blood Institute at the National Institutes of Health to advance their AI-based ECG analysis for mobile therapeutic monitoring of atrial fibrillation patients. SafeBeat is backed by top investors including Y Combinator, 50 Years, and Fusion Fund.
Patient Monitoring
Event Monitoring
Therapeutic Monitoring
Before adopting Ultralight, SafeBeat grappled with several challenges that impeded their growth and innovation:
Documentation Burden
The team struggled to maintain extensive documentation separate from their codebase, leading to inconsistencies and outdated information as code was updated.
Slow Software Release Cycles
The disconnect between code and documentation slowed down their ability to maintain the latest source of truth on their design history file documentation.
Engineering + Quality Siloes
SafeBeat's engineering and quality teams worked in isolated systems, leading to data drift and communication gaps.
Traceability Issues
Maintaining traceability between requirements, code, and test results was a manual and error-prone process.
Why SafeBeat
Chose Ultralight
SafeBeat selected Ultralight for its comprehensive SaMD-focused product and compliance hub, which promised to address their specific needs:
Modern & 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.
As an engineering leader, I appreciate that Ultralight places so much emphasis on serving engineering stakeholders. Ultralight has significantly streamlined our development processes, enabling us to accelerate product cycles while ensuring regulatory compliance. By automating documentation and integrating quality into our engineering workflow, we've saved valuable time and prevented data drift. The platform has enhanced collaboration between our engineering and quality teams, fostering a more efficient and cohesive development environment.
Vinko Buble
Head of Backend Engineering, SafeBeat
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.
Before partnering with Ultralight Labs, we faced significant obstacles in managing our quality processes. The burden of maintaining extensive documentation outside of our codebase led to inconsistencies and outdated information, especially as code evolved. Our software release cycles were delayed due to the disconnect between code and documentation, and the silos between engineering and quality created communication gaps and data drift. Additionally, ensuring traceability between requirements, code, and test results was a manual and error-prone task. Ultralight's platform has been instrumental in overcoming these challenges, allowing us to streamline operations and focus on innovation.
Rania deLeon
Head of Quality & Regulatory, SafeBeat
