What Ultralight Labs does

Ultralight Labs was a venture-backed SaaS company, founded in 2022 by Monik Sheth (CEO) and Shiv Ghai (CTO), that built an AI-native product development and compliance platform for the medical device industry. The platform unified requirements management (design control, ISO 14971 risk management, traceability, and test management), a configurable ISO 13485-aligned quality management system (document and change control with FDA 21 CFR Part 11 digital signatures, training, supplier management, CAPAs/nonconformances, parts), and compliance management with checklist templates for standards including IEC 62304 and ISO 11137. An embedded AI Copilot assisted users in writing verifiable requirements, generating hazard analyses, and producing rigorous test procedures, while a separate SaMD/SiMD module extended coverage to software-enabled devices via SBOM management, automated vulnerability scanning, and documentation-in-code workflows integrated with GitHub. Two free AI tools — Ultralight Insights (tailored FDA/510(k) digests) and Predicate Device Search — served as top-of-funnel acquisition vehicles.

The company sold on a quote-based annual subscription model via direct enterprise sales and self-serve onboarding (customers reportedly live in ~2 hours), targeting medical device startups through large medtech firms. Named customers included Brevitest, SafeBeat, Tenzr Health, and Sonosa Medical — all early-stage innovators in diagnostics, cardiac SaMD, and wearables — and the company reported helping "dozens" of medtech innovators with claimed outcomes such as 17% faster product cycles and 22% reduction in quality costs. Ultralight Labs raised approximately $2.7M in a July 2023 seed round (with a concurrent $3.5M SEC 506(b) filing, $2.68M sold) and was acquired by Greenlight Guru, a 1,000+ customer eQMS incumbent, on June 17, 2025, becoming part of Greenlight Guru's quality management ecosystem.

Name

Ultralight Labs

Legal name

Ultralight Labs, Inc.

Website

https://ultralightlabs.com

Company type

Private

Founded year

2022

Operating status

Acquired

Headcount range

1–10 employees

Short description

Ultralight Labs built an AI-native SaaS platform that unified requirements management, quality management, and compliance workflows for medical device companies, with a specialized SaMD/SiMD module and GitHub documentation-in-code integration. Acquired by Greenlight Guru in June 2025.

Ownership category

akta.pro rank

Product category

Medical Device Compliance Software

NAICS

Testing Laboratories and Services (541380)

SIC

Laboratory Analytical Instruments (3826)

akta.pro primary industry

Quality Management & Regulatory Compliance (CLIA/CAP/ISO) for Labs (HLACAMAH)

Keywords

• Medtech compliance software
• Medical device QMS
• Design control software
• Regulatory compliance platform
• SaMD development tools

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure

Revenue model

1. SaaS Subscription: Software-as-a-service subscription model providing access to the platform including requirements management, quality management, compliance tools, and support services. Pricing is quote-based and customized for each organization.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Ultralight Labs provides an all-in-one SaaS medtech product and compliance hub for medical device companies, combining AI-powered requirements management, ISO 13485-compliant quality management system, compliance management for standards such as ISO 14971 and IEC 62304, and a specialized SaMD/SiMD module. The platform unifies design control, risk management, traceability, test management, document control, and an AI Copilot that helps teams write requirements, generate hazard analyses, and create test procedures.

Product overview

Ultralight Labs offered an all-in-one medtech product and compliance hub as a unified SaaS platform combining three core modules: Requirements Management (AI-powered design control, ISO 14971 risk management, traceability, test management), Quality Management (ISO 13485-compliant document control, training, supplier management, quality events), and Compliance Management (checklist templates for FDA-recognized standards, integrated evidence, project management). A built-in AI Copilot assisted with requirements writing, hazard analysis creation, and test procedure development. A specialized SaMD/SiMD Software Module supported IEC 62304 compliance, SBOM management, and automated test documentation. Free tools included Ultralight Insights (FDA regulatory newsletter) and Predicate Device Search (510(k) predicate finder). The company was acquired by Greenlight Guru in June 2025.

Differentiator

Problem solved

Functional benefit

Products and services

• Requirements Management Module AI-powered requirements management module for medtech product development, providing multi-level requirements management, fast filtering and search, seamless Design History File generation, and end-to-end traceability from risks to requirements to testing. Designed for medical device companies needing intuitive design control and ISO 14971-compliant risk management.
• Quality Management Module ISO 13485-compliant quality management system module featuring flexible document and change control with FDA CFR Part 11-compliant digital signatures, automated training management, supplier approval workflows, configurable quality event workflows (CAPAs, nonconformances, complaints), and parts/inventory management. Built for modern medical device quality teams.
• Compliance Management Module Compliance management module providing checklist templates for ISO 14971, IEC 62304, ISO 11137, and other FDA-recognized consensus standards, integrated evidence management linking quality and requirements data, project management with owner assignment, and declaration of conformity generation. Targeted at medical device companies managing compliance beyond ISO 13485.
• AI Copilot for Medtech Built-in AI assistant purpose-built for medtech product development that helps users write more effective requirements, automatically screen requirements for verifiability, create hazard analyses in minutes, and ensure rigorous test procedures. Designed for medical device engineering and quality teams.
• SaMD/SiMD Software Module Specialized module for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) companies, supporting IEC 62304 compliance, SBOM management with automated vulnerability scanning, automated test documentation for software releases, requirements traceability for algorithmic components, and cybersecurity compliance.
• Ultralight Insights Free AI-powered monthly newsletter that condenses FDA guidances, 510(k) summaries, and adverse events into digestible summaries tailored to the subscriber's medical device interests, delivered directly to inbox. Targeted at medical device regulatory, quality, and engineering professionals.
• Predicate Device Search Free AI-powered search tool that identifies potential predicate devices from FDA 510(k) summaries, helping medical device teams determine regulatory pathway, assess competitive solutions, and find established benchmarks for device clearance or approval.

Quantifiable outcome

• 17% faster product cycles
• +6 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability8 records

Feature10 records

Partnerships

One partnership is on record.

• Greenlight GurucoreStrategic or Co-development Partner · 17 June 2025Ultralight Labs was acquired by Greenlight Guru, a provider of electronic quality management systems for the medical device industry. This merger combines Ultralight's modern medtech product development platform with Greenlight Guru's regulatory expertise and global reach, trusted by 1,000+ medical device customers worldwide. The acquisition enables dramatic scaling of impact in the medical device industry.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Jama Software: Requirements management and traceability platform for medical devices, automotive, and aerospace. Directly overlaps with Ultralight's Requirements Management module and risk-to-test traceability, often used by medtech QA teams.
• Qualio: Cloud eQMS platform built for life sciences startups and mid-market medical device companies. Directly competes with Ultralight in offering modern, easier-to-implement QMS for ISO 13485 and FDA-compliant quality systems.
• MasterControl: Long-standing eQMS and quality management software provider for life sciences and medical device companies. Competes head-to-head with Ultralight in document control, change control, training, and ISO 13485 compliance for regulated manufacturers.
• Greenlight Guru: Provider of electronic quality management systems (eQMS) for the medical device industry, serving 1,000+ customers worldwide. Direct overlap with Ultralight on QMS, design controls, and FDA compliance tooling; Greenlight Guru is also Ultralight's acquirer.
• Dot Compliance: AI-powered eQMS platform purpose-built for life sciences and medical device companies. Overlaps with Ultralight on Salesforce-native QMS, document control, training, and CAPA workflows for regulated manufacturers.

Emerging players

• Propel: Product lifecycle management (PLM) and quality management platform for medical device and high-tech manufacturers. Competes with Ultralight on design controls, requirements traceability, and supplier management, with stronger PLM depth.
• ComplianceQuest: Salesforce-native eQMS for life sciences and medical device companies. Competes with Ultralight on document control, change management, CAPAs, training, and supplier quality in regulated medtech environments.
• Arena Solutions (PTC): Cloud PLM and quality management platform owned by PTC, used by medical device and high-tech manufacturers. Competes with Ultralight on design control, BOM management, and quality workflows, with stronger PLM/engineering depth.

Broad incumbents

• Veeva Systems: Enterprise cloud software provider for life sciences, including Veeva Vault Quality and Vault QMS. Competes with Ultralight in regulated quality and compliance but as part of a much broader clinical, regulatory, and commercial portfolio serving large pharma and medtech.
• Siemens Polarion: Application lifecycle management (ALM) and requirements management tool used by medical device software teams for IEC 62304 compliance. Competes with Ultralight in SaMD/SiMD software traceability and verification workflows, as part of Siemens' broader PLM portfolio.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/ultralightlabs

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Ultralight Labs