Greenlight Guru

Greenlight Guru

Quality management software for medical devices

Overview

Greenlight Guru provides quality management software for the medical device industry to help companies stay compliant with regulations and improve product quality. The platform is cloud-based and includes modules for document control, CAPA (corrective and preventive actions), risk management, supplier management, complaint handling, audit readiness, and change control. It works by organizing all quality and regulatory activities in one system, automating workflows, enabling traceability, and providing real-time dashboards and reports to support inspection readiness and ongoing compliance. It differentiates itself from competitors by focusing specifically on medical devices, developed by industry experts, and offering an end-to-end, scalable solution that covers the full quality management lifecycle. The goal is to help medical device teams bring safe, effective products to market faster and maintain high quality throughout a product’s life cycle.

About Greenlight Guru

Simplify's Rating
Why Greenlight Guru is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Enterprise Software

Healthcare

Company Size

51-200

Company Stage

Growth Equity (Venture Capital)

Total Funding

$122.6M

Headquarters

Indianapolis, Indiana

Founded

2013

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Simplify's Take

What believers are saying

  • Ed Holmes' CEO appointment drives MedTech QMS strategic growth.
  • Alpha Sophia partnership enhances healthcare targeting and customer outreach.
  • $120M JMI Equity investment in 2021 fuels platform expansion.

What critics are saying

  • MasterControl erodes market share with broader compliance tools in 12-24 months.
  • ETQ Reliance captures enterprise clients via superior CAPA, causing 15-25% churn.
  • EU AI Act mandates recertification of AI features, halting updates by August 2026.

What makes Greenlight Guru unique

  • Greenlight Guru builds QMS exclusively for medical device lifecycle compliance.
  • Platform links design controls, risk management, and CAPA in one system.
  • MedTech Suite modernizes quality, accelerates design, and improves clinical trials.

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Funding

Total Funding

$122.5M

Above

Industry Average

Funded Over

3 Rounds

Growth Equity VC funding comparison data is currently unavailable. We're working to provide this information soon!
Growth Equity VC Funding Comparison
Coming Soon

Benefits

Flexible Paid Time Off

Home Office stipend for new hires

Health Insurance

Dental Insurance

Vision Insurance

401k (with company match)

Equity Program Eligibility (based on role and/or tenure)

Paid Maternity and Paternity Leave

Disability insurance

Growth & Insights and Company News

Headcount

6 month growth

2%

1 year growth

2%

2 year growth

-2%
MedCity News
Oct 4th, 2024
StartUPDATES: New Developments from Healthcare Startups

Alpha Sophia is thrilled to announce a new partnership with Greenlight Guru, combining its advanced healthcare targeting platform with their industry-leading quality management system.

WhaTech
Aug 29th, 2024
Quality Management Software Market Set to Surge to USD 24.64 Billion By 2032 As Revealed In New Report

In April 2023, Greenlight Guru, a cloud-based software solutions developer for MedTech companies, announced the launch of Export API.

Cision
Aug 27th, 2024
Greenlight Guru Announces the Appointment of Ed Holmes as CEO

Greenlight Guru announces the appointment of Ed Holmes as CEO.

Greenlight Guru
May 29th, 2024
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

For two year's and counting, Greenlight Guru has been named a quality management software Leader according to G2 Crowd, based on high customer satisfaction scores and its large market presence.

Cision
Feb 9th, 2024
Greenlight Guru Announces the 2024 True Quality Roadshow

INDIANAPOLIS, Feb. 9, 2024 /PRNewswire-PRWeb/ - Greenlight Guru, the leading provider of cloud-based quality and clinical software for MedTech companies, today announced its 2024 True Quality Roadshow-a four-city, international gathering of medical device professionals and industry stakeholders.

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