Greenlight Guru

What Greenlight Guru does

Greenlight Guru, founded in 2013 and headquartered in Indianapolis, is a privately held software company that sells a purpose-built quality management and clinical evidence platform exclusively to medical device companies. Its MedTech Suite consists of two core products: Greenlight Guru Quality, an electronic Quality Management System (eQMS) covering document control, CAPA, nonconformance, complaint handling, audit management, supplier management, training, and change management; and Greenlight Guru Clinical (formerly SMART-TRIAL), an Electronic Data Capture (EDC) platform for medical device clinical trials, PMCF surveys, and ePRO/eCOA data collection. The platform is built for FDA 21 CFR Part 820/Part 11, EU MDR, ISO 13485, ISO 14971, and ISO 14155 compliance and includes an integrated Product Development module linking design controls, risk management, and requirements traceability.

The company generates revenue through annual subscription contracts, priced separately for the Quality and Clinical modules and sold quote-based rather than on published price lists. Go-to-market combines enterprise field sales for large MedTech organizations, inside sales for mid-market accounts, and self-serve educational content (blog, podcast, Academy, ROI calculator) for top-of-funnel demand generation. The company has expanded the platform through five acquisitions since 2022: CanvasGT (collaborative design, January 2022), Vertex Intelligence (AI/ML, May 2022), SMART-TRIAL (EDC, June 2022), Ultralight Labs (merger, August 2025), and Enzyme (2025). Greenlight Guru reports more than 1,000 medical device company customers and 500+ clinical studies supported, and the platform holds ISO 9001, ISO 27001, and SOC 2 Type 2 certifications. The company is led by CEO David DeRam with founder Jon Speer, and has received $120 million in growth equity from JMI Equity (2021) and a $1.25M earlier round in 2015.

Name

Greenlight Guru

Legal name

Greenlight Guru

Website

https://greenlight.guru

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

101–250 employees

Short description

Greenlight Guru provides a purpose-built cloud quality management (eQMS) and clinical evidence (EDC) platform exclusively for medical device companies, serving 1,000+ customers across pre-market, post-market, and CRO workflows with integrated AI features.

Ownership category

akta.pro rank

Product category

Medical Device Quality Management Software

NAICS

Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Electronic Data Capture (EDC) Platforms (HLACAOAA)

Keywords

• Medical device QMS
• Electronic data capture
• Quality management software
• Clinical evidence software
• Regulatory compliance software

Headquarters

HQ city

Indianapolis

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Subscription-based eQMS (Quality): Annual or multi-year subscription for the quality management module. Priced separately from the clinical module, with the platform offered as a unified suite. Sold directly to medical device companies via enterprise sales motion.
2. Subscription-based EDC (Clinical): Annual or multi-year subscription for the clinical evidence / EDC module. Sold separately or as part of an integrated suite. Supports clinical trial data collection from first-in-human studies through post-market surveillance.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels8 records

Core offering

Greenlight Guru provides a cloud-based, purpose-built Quality Management System (eQMS) and Electronic Data Capture (EDC) platform exclusively for medical device companies. The platform unifies quality events, design controls, risk management, document control, training, supplier management, and clinical evidence collection across the full device lifecycle, with built-in compliance for FDA 21 CFR Part 820/Part 11, EU MDR, ISO 13485, ISO 14971, and ISO 14155. Two core products (Greenlight Guru Quality and Greenlight Guru Clinical) are sold primarily on annual subscriptions to MedTech organizations of all sizes.

Product overview

Greenlight Guru offers a unified MedTech Suite platform consisting of two core products: Greenlight Guru Quality (eQMS) and Greenlight Guru Clinical (EDC), complemented by specialized modules for CAPA Management, Document Management, Risk Management, Training Management, Design Controls, Complaint Management, Nonconformance Management, Supplier Management, Audit Management, Change Management, Requirements Management, Software Release Management, eCRF, ePRO, and PMCF. The platform is purpose-built for medical device companies with AI-powered features for brainstorming, QMS chat, global search, and training analytics. Guru Edge provides additional value-added services including customer success, professional development (Academy), and expert guidance packages.

Differentiator

Problem solved

Functional benefit

Products and services

• Greenlight Guru Quality
• Greenlight Guru Clinical Electronic Data Capture (EDC) system purpose-built for medical device clinical trials, enabling compliant clinical data collection across pre-market investigations, PMCF studies, and post-market surveillance with ISO 14155 alignment.
• Guru Edge Comprehensive service package including dedicated customer success team, professional development through Academy, expert guidance (Guru Assist, Strategic Guru, Complete Guru), and industry-specific support services sold alongside the Quality and Clinical subscriptions.

Quantifiable outcome

• Trusted by 1,000+ medical device companies globally
• +4 more outcomes

Named customers15 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability5 records

Feature6 records

Partnerships

Four partnerships are on record, tiered notable and core.

• Ultralight LabsnotableStrategic or Co-development Partner · 1 January 2025Ultralight Labs merged into Greenlight Guru, with the intent to enhance product development and regulatory compliance capabilities within the platform.
• Google DrivecoreTechnology or IntegrationPlatform integration with Google Drive enabling document storage and collaboration within the regulatory compliance environment of the Greenlight Guru QMS.
• Microsoft Office for WebcoreTechnology or IntegrationPlatform integration with Microsoft Office for Web enabling seamless document creation and collaboration within the quality management and regulatory compliance environment.
• Medical Device Partner EcosystemcoreStrategic or Co-development PartnerGreenlight Guru maintains a network of medical device partners providing industry expertise, complementary services, and go-to-market collaboration as part of the Guru Edge program.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• MasterControl: Direct MedTech-focused eQMS competitor offering quality management, document control, and compliance solutions for life sciences manufacturers, with the deepest installed base among purpose-built device QMS vendors.
• Qualio: Cloud eQMS purpose-built for life sciences, with particular strength in startup and mid-market MedTech — directly comparable in vertical focus, pricing model, and target customer profile to Greenlight Guru.
• ComplianceQuest: Native Salesforce-based QMS and EHS platform for life sciences, including MedTech; competes head-to-head in regulated quality management and was listed alongside Greenlight Guru as a top FDA compliance provider.

Broad incumbents

• Veeva Systems (Veeva Vault Quality): Dominant life-sciences cloud platform with Vault Quality, Vault Clinical, and Vault RIM modules spanning pharma, biotech, and MedTech — broader than Greenlight Guru but increasingly overlapping in device QMS and clinical.
• Sparta Systems (TrackWise, by Honeywell): TrackWise QMS and TrackWise Digital serve regulated manufacturers including MedTech; an established enterprise incumbent often compared directly with Greenlight Guru in MedTech quality shortlists.
• ETQ (Hexagon): Enterprise QMS platform serving multiple regulated industries including medical devices and life sciences; broader portfolio and larger enterprise footprint, frequently benchmarked against Greenlight Guru in MedTech deals.
• Arena Solutions (PTC): Cloud PLM and quality platform from PTC serving medical device and high-tech OEMs; broader scope than Greenlight Guru but directly comparable on design controls, requirements, and quality traceability.

Emerging players

• Dot Compliance: AI-enabled QMS built on Salesforce targeting life sciences and MedTech; an emerging competitor with a similar vertical SaaS thesis and an emphasis on AI-driven quality automation.
• Propel Software: Product lifecycle management (PLM) and QMS for high-tech and MedTech manufacturers; competes on product development, design controls, and quality traceability — overlapping with Greenlight Guru's product development module.
• SmartSolve (Pilgrim Quality Solutions): QMS and supplier quality management platform serving life sciences and MedTech; competes in regulated quality management with comparable eQMS and supplier management capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/greenlightguru

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries5 records

Funding overview

Funding rounds2 records

Investors1 record

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

M&A4 records

Investments

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

Frequently asked questions about Greenlight Guru