Ultralightlabs
“Can a modern, AI-native QMS displace legacy medtech compliance tools — or is it better absorbed by the incumbent?”
Founded2022
HQUnited States
FoundersMonik Sheth
IndustryVertical SaaS / Medtech (QMS & Compliance)
The story
Ultralight Labs was founded in 2022 to modernize medtech product development and QMS/compliance tooling (ISO 13485, ISO 14971, IEC 62304, FDA CFR Part 11). It positioned itself as a startup-friendly alternative to Qualio and other legacy eQMS platforms. In June 2025, the company was acquired by Greenlight Guru, the dominant medtech QMS incumbent, folding Ultralight's AI-powered requirements management into a broader platform.
Last 12 months
2025-06
Product timeline
2022
Ultralight Labs founded to build modern QMS and requirements management for medical device companies· pivot
2023
Launched Ultralight Insights and AI Predicate Device Search· pivot
2025
Acquired by Greenlight Guru· acquisition
The stack
0 layers disclosed in Ultralightlabs’s embedded-finance stack
Accounting gap: none