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
- Quote-based
- 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.
Features & capabilities
Document & Change Control
Version-controlled documents with full change traceability.
- Document version control and approval workflows
- Change management with full traceability and impact assessment
- Audit trails
Quality Events (CAPA, Complaints, Non-Conformance)
Quality issue handling linked to design elements.
- CAPA management with root cause analysis
- Complaint handling
- Non-conformance tracking
- Full traceability to design elements and documents
Training & Supplier Management
Training and supplier oversight tied to quality events.
- Training tied to document updates and quality events
- Training analytics
- Supplier risk-based oversight and evaluation
Risk & Audit Management
Device risk management and audit tracking.
- Risk management aligned to ISO 14971
- Internal, supplier and compliance audit management
- Audit planning and tracking
Product Development & Design Controls
Requirements-to-verification traceability for device submissions.
- Requirements management
- Design controls and traceability
- Design History File (DHF) management
- Software release management for SiMD/SaMD
AI-Powered Workflows
AI assistance layered across the QMS.
- AI-generated summaries of QMS context
- AI-assisted change impact assessment
- Automated traceability gap detection
- AI-generated training quizzes from documents
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
Pricing
Pricing is not published; Greenlight Guru quotes separately for its Quality and Clinical products based on company size and modules selected. Get an independent shortlist with pricing guidance below.
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)
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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.
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