+
+

Related Products

  • Qualio
    919 Ratings
    Visit Website
  • Propel
    212 Ratings
    Visit Website
  • AlisQI
    108 Ratings
    Visit Website
  • isoTracker Quality Management
    19 Ratings
    Visit Website
  • MRPeasy
    252 Ratings
    Visit Website
  • Resource Guru
    1,043 Ratings
    Visit Website
  • Lockbox LIMS
    72 Ratings
    Visit Website
  • Retreat Guru
    134 Ratings
    Visit Website
  • Epicor Connected Process Control
    4 Ratings
    Visit Website
  • Intelex
    180 Ratings
    Visit Website

About

Trusted by over 1,000 medical device manufacturers, Greenlight Guru is a quality management system built for the medtech industry. The platform is architected around regulatory reality, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not added later. Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you skip the separate validation project and go live faster. Greenlight Guru integrates AI-powered automation to reduce manual work while maintaining the audit trail and documentation rigor your business requires. With 15 years in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and sustain commercial success.

About

RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory

Audience

Medical technology companies in search of a solution to manage their compliance and regulation processes

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations

Pricing is custom scoped.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 4.4 / 5
ease 4.5 / 5
features 4.5 / 5
design 4.4 / 5
support 4.4 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Pros & Cons from Real Users

Pros

  • What I like most about Greenlight Guru is how organized and user-friendly the platform is. It makes it much easier to manage documentation, keep track of processes, and maintain everything in one place. The workflow is straightforward, and having everything centralized saves a lot of time compared to managing things manually.
  • Easy-to-use interface for managing quality and compliance documentation. Strong traceability between requirements, risks, tests, and design controls. Centralized document management improves team collaboration and audit preparedness. Helpful customer support and onboarding experience. Saves time by streamlining regulatory and quality management processes.
  • Easy to search, easy to navigate, like that is accessed via web. The pricepoint is competitive compared to other platforms. It is ISO 13485 compliant
  • Greenlight Guru provides a well-organized platform for managing quality processes and documentation. The interface is straightforward, and having quality-related information in one centralized location makes collaboration and document management much easier.
  • Easy UI. Great theme; professional. Very well structured. Easy to navigate. Great reminder feature.

Cons

  • The platform can take some time to get used to when you first start using it, especially with all of the features and options available. Some areas could also be a little more intuitive, but once you become familiar with the system, it is fairly easy to navigate.
  • Some areas of the platform can occasionally feel slow when working with large datasets. Reporting and workflow customization options could be more flexible. Initial setup and configuration may require time for new users.
  • CO process is very complicated, the uploading process and the "checking out" of the documents is very complicated. there is no collaboration workflow. It requires word documents for some aspects of the CO, but PDFs for other. Very hard to get it right without the intervention of documents control. Should include an option to allow user to see redlines from the documents page, rather than having to download the CO packet.
  • Some workflows can take time to learn, especially for new users. Certain areas of the interface could also be more intuitive, and additional flexibility or customization would make everyday tasks easier.
  • Would love an AI summary feature to quickly summarize long documents when feasible

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

RQM+
United States
www.rqmplus.com

Alternatives

Alternatives

Propel

Propel

Propel Software
ZipQuality

ZipQuality

Consensia
Jama Connect

Jama Connect

Jama Software
Matrix Req

Matrix Req

Matrix One
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru

Categories

Categories

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Not Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Supported
Maintenance Management Not Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

GitHub Supported
Google Drive Supported
Jira Supported
Microsoft 365 Supported

Integrations

GitHub Not Supported
Google Drive Not Supported
Jira Not Supported
Microsoft 365 Not Supported
Claim Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
Claim RQM+ and update features and information
Claim RQM+ and update features and information