Greenlight Guru

Quality management and clinical data software built specifically for medical device companies

No reviews yet United States Founded 2013
Who works with Greenlight Guru?

Small, mid-size and enterprise organizations in Healthcare in United States.

What is Greenlight Guru?

Greenlight Guru, based in Indianapolis, develops cloud software for medical device makers that combines a quality management system with clinical data capture. The QMS covers design controls and the design history file, risk management, document and change control, CAPA, complaints, nonconformance, audits, supplier and training records. The clinical side supports electronic case report forms, patient reported outcomes and post-market surveys. The company states that it serves more than 1,100 medical device companies, from pre-market startups to enterprise manufacturers and contract research organizations, and its stated mission is to improve quality of life for customers and patients.

Services and products

  • Design control and DHF
  • Risk management
  • Document and change management
  • CAPA and nonconformance management
  • Complaint management
  • Audit and supplier management
  • Electronic data capture for clinical studies

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