Greenlight Guru
Greenlight Guru offers the #1 QMS for medical devices, providing an eQMS designed for medtech innovators to ensure compliance and streamline product development.
Greenlight Guru is the leading Quality Management System (QMS) provider for medical device companies. Their comprehensive eQMS is built for product-led, fast-moving medtech innovators, helping them stay organized, compliant, and audit-ready throughout the entire product lifecycle. Trusted by over 1,000 medical device companies, Greenlight Guru combines AI-powered software with deep industry expertise. They offer solutions for QMSR transition readiness, CAPA management, and design controls, ensuring that companies can navigate complex regulations like FDA's QMSR and ISO 13485. Their platform is designed to be flexible, integrating with existing tech stacks and providing guardrails to guide teams. Greenlight Guru empowers engineers and auditors alike, focusing on product development rather than excessive paperwork, and facilitating global scale with audit-tested quality workflows.
About
**Who they are**
Greenlight Guru provides the #1 Quality Management System (QMS) for medical devices, offering an electronic QMS (eQMS) specifically designed for medtech innovators. They focus on ensuring compliance and streamlining product development.
**Expertise & scope**
* Specializes in QMSR transition and inspection readiness, with resources to prepare for FDA's Quality Management System Regulation.
* Offers solutions for CAPA (Corrective and Preventive Action) management, integrating fully with their QMS to address systemic issues and reduce duplicate CAPAs.
* Provides guidance and tools for ISO 13485 compliance, covering essential documentation requirements like Quality Manuals, Medical Device Files, and Document Control.
* Expertise in Design Controls for medical device companies, addressing the complexities of product development regulations.
* Supports product development by fitting processes rather than forcing them, allowing teams to focus on product innovation.
**Reputation / proof points**
* Trusted by over 1,100 of the world's leading MedTech companies.
* Offers an eQMS built for product-led, fast-moving medtech innovators and established, expanding teams.
* Provides an eQMS designed for data collection and management in medtech clinical trials.
Greenlight Guru provides the #1 Quality Management System (QMS) for medical devices, offering an electronic QMS (eQMS) specifically designed for medtech innovators. They focus on ensuring compliance and streamlining product development.
**Expertise & scope**
* Specializes in QMSR transition and inspection readiness, with resources to prepare for FDA's Quality Management System Regulation.
* Offers solutions for CAPA (Corrective and Preventive Action) management, integrating fully with their QMS to address systemic issues and reduce duplicate CAPAs.
* Provides guidance and tools for ISO 13485 compliance, covering essential documentation requirements like Quality Manuals, Medical Device Files, and Document Control.
* Expertise in Design Controls for medical device companies, addressing the complexities of product development regulations.
* Supports product development by fitting processes rather than forcing them, allowing teams to focus on product innovation.
**Reputation / proof points**
* Trusted by over 1,100 of the world's leading MedTech companies.
* Offers an eQMS built for product-led, fast-moving medtech innovators and established, expanding teams.
* Provides an eQMS designed for data collection and management in medtech clinical trials.
Additional information
Greenlight Guru's platform is built to support the entire product lifecycle for medical device companies. Their eQMS is designed to integrate with existing tech stacks, offering guardrails to guide teams and ensure compliance throughout development and production. The system is audit-tested and built for global scale, addressing the need for flexible quality workflows that adapt to how teams work. They emphasize staying focused on product development rather than getting bogged down in paperwork, making compliance a more integrated part of the innovation process.
Key Highlights
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Offers the #1 QMS for medical devices, an eQMS designed for medtech innovators.
Source
“Greenlight Guru offers the #1 QMS for medical devices, providing an eQMS designed for medtech innovators to ensure compliance and streamline product development.”
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Provides a QMSR Resource Hub to prepare for FDA's Quality Management System Regulation, emphasizing compliance by February 2, 2026.
Source
“QMSR has no grace period. Your quality system must be updated and aligned by February 2, 2026.”
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Features integrated CAPA management software designed to address systemic issues and reduce duplicate CAPAs.
Source
“Addresses: addresses each one; address systemic issues and reduce the chance of creating duplicate or repeated CAPAs”
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Offers comprehensive guidance on ISO 13485 for Medical Devices QMS, including documentation requirements.
Source
“ISO 13485: Ultimate Guide to Medical Devices QMS; What is ISO 13485?; Traceability; Evolution of a Quality Management System; Requirements for ISO 13485 Certification; What is a Quality Management System?; ISO 13485 Documentation Requirements; 1. Quality Manual; 2. Medical Device File; 3. Document Control”
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Provides a guide to Design Controls for Medical Device Companies, emphasizing traceability and risk management.
Source
“The Ultimate Guide To Design Controls For Medical Device Companies; What’s this guide about anyway?; You have an idea for a new medical device. Now what?”
Certifications & Trust Signals
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Trusted by over 1,100 of the world's leading MedTech companies.
Source
“1,100+ of the world’s leading MedTech companies trust Greenlight Guru.”
Buyer Snapshot
Best for
- Medtech innovators requiring a compliant QMS
- Companies preparing for QMSR transition
- Organizations needing integrated CAPA management
- Medical device firms focused on design controls and ISO 13485
How engagement typically works
- Demo-driven sales process
- Focus on eQMS implementation and support
Typical deliverables
- eQMS software platform
- QMSR readiness resources (playbooks, checklists)
- CAPA management tools
- ISO 13485 documentation support
- Design controls guidance
Good to know
- Best when seeking a dedicated medical device QMS solution.
Pricing
Model:
Custom pricing
HQ:
Indianapolis, USA
Languages:
English
Timezones:
EST, CST, PST
Status:
listed
Services & Capabilities
FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, IVD
Onboarding time:
7–14 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, Design Controls / DHF Modernization, CAPA & Nonconformance Remediation, SOP / Documentation Remediation
Earliest Start:
flexible
Delivery Mode:
Hybrid
Inspection Experience:
ISO 13485 lead auditor capability
Additional fda_qmsr_transition_inspection_readiness Details
Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Training & Competency Programs
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
