Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
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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

Greenlight Guru Clinical is the only electronic data capture (EDC) system built specifically for medical device and diagnostics companies, not adapted from pharma. Designed exclusively for medtech, it combines an easy to use clinical data platform with industry leading customer service, helping teams generate reliable, compliant clinical data under FDA, EU MDR, IVDR, and ISO 14155 requirements. Get a single, validated platform for medical device studies, including: Electronic Data Collection and eCRF ePRO/eCOA (electronic patient and clinician reported outcomes) eConsent Randomization (RTSM) PMCF Surveys (post market clinical follow up) Adverse Events Reporting Open API Used by device manufacturers and medtech CROs running clinical investigations, PMCF studies, registries, and human factors testing. Every customer gets a dedicated customer success manager with real medtech experience and a validation package included with every product update.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

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

Audience

Medical Device Manufacturers

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

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
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 4.3 / 5
ease 4.3 / 5
features 4.0 / 5
design 4.0 / 5
support 3.7 / 5

Reviews/Ratings

Overall 4.0 / 5
ease 4.0 / 5
features 4.0 / 5
design 4.5 / 5
support 4.0 / 5

Pros & Cons from Real Users

Pros

  • The platform is straightforward and easy to navigate. I especially like having training assignments, documents, and completion status organized in one place.
  • Easy to maneuver and operate, with a user-friendly design that makes it simple to navigate and handle. It provides a smooth, convenient experience without requiring much effort.
  • Easy to navigate and easy to use. It was really straightforward to learn how to use the product and complete what I needed to.

Cons

  • Occasionally, the login or password reset process could be smoother. Improving that experience would make the platform even easier to use.
  • The controls may take a little time to get used to.
  • Honestly, there isn't much I didn't like. It works well!

Pros & Cons from Real Users

Pros

  • Can be easily programmed by someone without experience coding or with software. Simple to implement rules and validations. Intuitive to use for sites and study staff. Non-blocking amendments is a great addition in the last year.
  • It is easy to navigate and use. Everything is clearly labelled. Always support from the data team. Queries are clearly labelled and simple to answer.

Cons

  • Can be a bit restrictive, for example cannot use calculated values in a validation rule which makes it more difficult to implement controls for inclusion and exclusion criteria. Export labels can be difficult to work with. Skipped or missing visits can cause issues. SDV is difficult to verify only part of a visit.
  • Having to double answer why you are changing an answer. Can be time consuming.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

Greenlight Guru
Founded: 2013
Denmark
www.greenlight.guru/clinical-electronic-data-capture-software

Alternatives

Alternatives

Propel

Propel

Propel Software
TrialKit

TrialKit

Crucial Data Solutions
Jama Connect

Jama Connect

Jama Software
Fusion eClinical Suite

Fusion eClinical Suite

Axiom Real-Time Metrics
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru

Categories

Categories

Quality Management Features

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

Clinical Trial Management Features

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Electronic Data Capture Features

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
GitHub
Google Drive
Jira
Medidata
Microsoft 365
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault

Integrations

BSI CTMS
ChatGPT
Claude
Cursor
Gemini
GitHub
Google Drive
Jira
Medidata
Microsoft 365
Oracle Clinical One
Prelude EDC
Tremendous
Veeva Vault
Claim Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
Claim Greenlight Guru Clinical and update features and information
Claim Greenlight Guru Clinical and update features and information