G

greenlight-guru

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Greenlight Guru Market Research Report



Company Overview



Name and Mission


  • Company Name: Greenlight Guru

  • Mission: To improve the quality of life by solving challenges unique to medical device companies with innovative solutions and industry expertise.


Founding Information


  • Founded: 2006

  • Founders: Jon Speer and David DeRam


Key People


  • CEO: Ed Holmes

  • CTO: Brian Gaffney

  • CSO: Dan Thompson

  • CMO: Natalia Dykyj


Headquartered


  • Location: No information is available regarding the headquarters location.


Employees


  • Number of Employees: No information is available.


Revenue


  • Revenue: No information is available.


Reputation


  • Known For: Greenlight Guru is known as the leading provider of quality management system (QMS) software specifically designed for medical device companies.


Products



Greenlight Guru Quality


  • Description: A QMS software specifically designed for MedTech companies to enhance efficiency, track quality events, trace design controls to risk, and ensure compliance.

  • Key Features:

  • Cloud-based solution

  • Pre-validated per FDA & ISO best practices

  • End-to-end traceability

  • Real-time audit readiness

  • Document Management

  • Design Controls and DHF management

  • Training Management


Greenlight Guru Clinical


  • Description: Formerly known as SMART-TRIAL, this product offers a platform for the collection and management of clinical evidence, safety, and performance data in medical device studies.

  • Key Features:

  • FDA and ISO 14155:2020 compliant

  • 3-Step study builder

  • Electronic Case Report Forms (eCRF)

  • Secure SMS and Email data collection

  • Pre-validated post-market surveys

  • GCP compliant ad hoc data collection


Guru Services


  • Description: Provides expert consulting and guidance throughout the product lifecycle including regulations compliance, risk reduction, and audit preparation.

  • Key Features:

  • System Configuration & Implementation

  • Process Automation

  • Hands-on guidance from MedTech professionals

  • Templates for quality manuals, project, and risk plans


Recent Developments



Recent Developments


  • In 2022, Greenlight Guru acquired SMART-TRIAL, expanding its offerings in Electronic Data Capture solutions and further solidifying its position in the MedTech industry.

  • The company also acquired Vertex Intelligence, enhancing AI integration across its solution suite.


New Products


  • No specific new products launched have been reported.


Additional Features


  • The addition of integrated AI features through the acquisition of Vertex Intelligence.


Partnerships


  • Strategic partnerships with 1,100+ leading MedTech companies worldwide.


This structured and information-dense report captures the core aspects of Greenlight Guru's market presence and product offerings based on the available data, providing a valuable resource for stakeholders and industry analysts.

Note: For any fields marked with "No information is available," details were not provided in the data.
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