Ultralight Labs

Ultralight Labs provides an integrated software platform for medical device companies to manage product development, quality management, and regulatory compliance. The company has been acquired by Greenlight Guru and serves medtech companies developing hardware and software medical devices.

The platform combines requirements management, risk mitigation, quality management, and compliance tracking in a single system. Core capabilities include AI-powered requirements management, ISO 14971 risk management, FDA CFR Part 11-compliant document control, training management, supplier management, and traceability from risks through requirements to testing. The system includes templates for common standards including ISO 14971, IEC 62304, ISO 11137, and ISO 13485.

Notable features include AI copilot functionality for hazard analysis and requirements writing, automated migration capabilities for companies switching from existing QMS systems, and configurable workflows that allow organizations to customize document types, versioning schemas, and change order processes while maintaining validation and compliance.

Choose Ultralight Labs when you need to modernize medical device compliance processes with a platform that balances structure with flexibility. The platform excels for teams that have outgrown spreadsheets but want to avoid the complexity and rigidity of traditional enterprise QMS solutions.

Expect a user-friendly implementation with pre-built templates for common regulatory standards, combined with the ability to customize workflows to match your organization's specific processes. The AI copilot features and automated migration capabilities particularly benefit teams looking to accelerate compliance work without sacrificing quality or traceability.

Ultralight Labs serves exclusively the medical device sector within healthcare, providing compliance and product management software aligned with FDA and international medical device regulations. The platform addresses ISO 13485 quality management, ISO 14971 risk management, IEC 62304 software lifecycle, and ISO 11137 sterilization validation requirements.

Client base includes medical device startups and established medtech companies like Brevitest, Tenzr Health, and Sonosa Medical. The platform's healthcare focus centers on enabling regulatory compliance for medical device development rather than clinical operations or patient care delivery.

Medical device companies developing Class II or Class III devices that require ISO 13485, ISO 14971, and IEC 62304 compliance. Organizations with 10-100 employees that value modern software interfaces and need integrated management of design controls, risk management, and quality processes. Teams transitioning from spreadsheets or legacy systems who want to accelerate compliance without compromising regulatory requirements.