Greenlight Guru
by Greenlight Guru · Healthcare & Life Sciences
Cloud QMS, design-controls and clinical evidence platform built for medical device companies.
Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.
- Deployment
- Cloud
- Company size
- SMB, Mid-market, Enterprise
- Pricing
- Annual subscription, quote-based by users and modules
- Founded
- 2013
- Headquarters
- Indianapolis, Indiana, United States
Overview
Greenlight Guru is a cloud-based quality management and clinical evidence platform built specifically for medical device companies, spanning product development, quality management and clinical data collection. Founded in 2013 and headquartered in Indianapolis, Indiana, the company reports more than 1,000 medical device customers and has raised over $121M in funding, backed by JMI Equity.
The Quality Management System (QMS) product covers document control, change management, training tied to document updates, supplier quality management, quality events (CAPA, complaints, non-conformances), parts/BOM management and risk management aligned to ISO 14971. A separate Product Development module adds requirements management, design controls, software release management and Design History File (DHF) management, and a Clinical Evidence platform provides electronic data capture (EDC), post-market clinical follow-up (PMCF) and ePRO/eCOA tools.
Greenlight Guru's workflows are built around ISO 13485, ISO 14971, FDA 21 CFR Part 11, FDA QSR/QMSR and EU MDR requirements, and it documents integrations with Jira, SSO providers, PLM systems and EDC platforms plus a flexible API; ERP integration is referenced generically as a capability but no specific ERP vendor connector is published.
Screenshots & demo
Screenshots sourced from Greenlight Guru.
Modules & capabilities
Greenlight Guru covers 14 of 54 capabilities we track in this category (+1 partial)
26%- Document version control & approval workflowsDocument version control and approval workflows, dedicated feature groupCore strength
- Electronic signaturesNot evidenced
- Training linked to document changesTraining tied to document updates and quality eventsCore strength
- Training records & competency trackingTraining analyticsSupported
- SOP authoring & controlNot evidenced
- Collaborative document authoringNot evidenced
- Role-based document access controlNot evidenced
“Not evidenced” means our research found no public documentation of this capability — the vendor may still offer it. Confirm on a demo.
Common use cases
- Building and maintaining a Design History File (DHF) with requirements-to-verification traceability for a device submission
- Managing CAPAs, complaints and non-conformances with root-cause analysis linked to design elements
- Running risk management activities aligned to ISO 14971 across the device lifecycle
- Tracking supplier qualification and ongoing supplier quality oversight for a multi-supplier device manufacturer
- Collecting clinical trial data (EDC) and post-market clinical follow-up (PMCF) evidence for EU MDR compliance
- Assigning and tracking employee training automatically triggered by document changes
- Scaling quality processes for an early-stage medtech startup preparing its first FDA 510(k) submission
Strengths & considerations
Strengths
- Purpose-built exclusively for medical device companies rather than a general-purpose or multi-industry QMS
- Combines QMS, product development/design controls and a clinical evidence (EDC/PMCF) platform under one MedTech Suite
- AI-powered features (context summaries, change-impact assessment, automated traceability gap detection) built into the core workflow
- Reports 1,000+ medical device customers and involvement in 1,700+ 510(k) clearances and CE-marked devices
Used Greenlight Guru with your ERP? Rate it in 30 seconds — it helps every buyer after you.
Rate itPricing
Full Greenlight Guru pricing breakdown — cost at 25/100/500 seats, competitor rates & FAQs
Greenlight Guru starts around $15,000 a year and rises toward $50,000 to $60,000 as user counts grow. A significant caveat for 2026 budgets: the vendor announced substantial price rises from 2026, with reported increases approaching 100% without corresponding new functionality — so existing customers should model renewal explicitly rather than assuming continuity. It is a medical-device-specific eQMS, and that regulatory specialisation is what separates it from general quality platforms. Get an independent shortlist with pricing guidance below.
What does Greenlight Guru cost?
Greenlight Guru prices by quote, like most of this category. Here is what actually drives your number — and what to ask before you get one.
9 of the 12 vendors we track in this category publish no list price at all.
Technical & security
- Hosting
- SaaS (multi-tenant)
- Compliance
- ISO 13485, ISO 14971, 21 CFR Part 11, FDA QSR/QMSR, EU MDR
About the vendor
- Founded
- 2013
- Headquarters
- Indianapolis, Indiana, United States
- Employees
- ~145
- Ownership
- Private (backed by JMI Equity)
Alternatives to Greenlight Guru in Healthcare & Life Sciences
Greenlight Guru — frequently asked questions
What is Greenlight Guru's QMS built for?
It's purpose-built for medical device companies, covering document control, CAPA, complaints, non-conformances, training, supplier management and risk management aligned to ISO 14971 in one system.
What regulatory standards does Greenlight Guru support?
Its workflows are built around ISO 13485, ISO 14971, FDA 21 CFR Part 11, FDA QSR/QMSR and EU MDR requirements.
Does Greenlight Guru cover more than quality management?
Yes. Beyond QMS, it offers a Product Development module for design controls, requirements management and Design History File (DHF) management, and a Clinical Evidence platform for EDC and post-market clinical follow-up (PMCF).
How is Greenlight Guru priced?
Pricing is not published; Greenlight Guru quotes separately for its Quality and Clinical products based on company size and modules needed.
Who owns Greenlight Guru?
It is a private company backed by JMI Equity, having raised over $121M in funding since founding in 2013.
Compare Greenlight Guru head-to-head
The Healthcare & Life Sciences Buyer's Guide
Before you commit to Greenlight Guru, see how it sits against the 12 healthcare & life sciences systems we track — on capability, ERP integration depth and what each one actually charges for.
Healthcare & Life Sciences Buyer's Guide
12 systems compared · 2026
ERP Research
- Greenlight Guru compared side-by-side with 11 alternatives
- ERP integration checklist — what to verify before you shortlist
- The pricing questions that change the quote
- A Greenlight Guru evaluation brief, included with the guide
Healthcare & Life Sciences Buyer's Guide
Get a quote for Greenlight Guru
Greenlight Guru publishes a list price, but the number you pay depends on volume, modules and integration scope. Tell us your setup and we'll come back with a realistic figure and the alternatives worth quoting against it.