Average Ratings 5 Ratings
Average Ratings 0 Ratings
Description
Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, 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 configured later.
Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster.
Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires.
With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.
Description
RQM+ stands as a prominent global provider of medical technology services, dedicated to accelerating compliance and ensuring market success for its clients. With a wealth of expertise and deep industry insight, we offer tailored solutions that streamline the entire product lifecycle for medical technology firms, guiding them from initial concept through to commercialization and beyond. Our comprehensive suite of services facilitates seamless end-to-end solutions that encompass every stage of the medical device development process. The quality assurance engineers at RQM+ meticulously evaluate material lists, establish supplier networks, and assist in navigating the design change process. Likewise, our design quality engineers are instrumental in overseeing crucial aspects such as packaging, sterility, biocompatibility, and required device testing. Our regulatory affairs consultants play a vital role by providing expert guidance and assistance with submissions to the FDA, notified bodies, and other regulatory agencies. Additionally, we leverage our significant experience with current reimbursement requirements and value-based compensation frameworks to enhance our clients' market positioning. Ultimately, RQM+ is committed to empowering medical technology companies to achieve their goals efficiently and effectively.
API Access
Has API
API Access
Has API
Integrations
GitHub
Google Drive
Jira
Microsoft 365
Pricing Details
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.
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 Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
United States
Website
greenlight.guru
Vendor Details
Company Name
RQM+
Country
United States
Website
www.rqmplus.com
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management