Electronic Health Reporter

Greenlight Guru is the only quality management software designed specifically for the medical device industry.

Elevator pitch

Get to market faster with less risk and achieve true quality.

Founders’ story

The seeds for Greenlight Guru were planted back in 2006 by Jon Speer, a medical device engineer turned consultant as a result of a simple observation: paper-based quality management systems are painful, risky & wildly inefficient. Commercial quality management software solutions have been available for over 20 years now, yet only about 30 percent of medical device companies that should be using them were. This observation and question led Jon Speer to team up with David DeRam to create the vision for a beautifully simple quality management software.

Marketing/promotion strategy

Greenlight Guru partners with trade publications and frequently hosts webinars to help medical device startup founders plot a clear course through the complicated regulatory environment.

Market opportunity

Quality management solutions existed, or could be engineered to work, for nearly every industry. Because of to the complicated nature of medical device regulatory compliance in the United States, Canada and the European Union one of two things was happening: 1. Systems not meant for medical devices were being rigged to work or, 2. An unorganized, not easily searched paper-based QMS was developed.

Greenlight Guru was developed to help medical device manufacturers manage documents, manage risk, perform quality management and log and address customer complaints in an easy to use cloud-based platform.

Who are your competitors?

Greenlight Guru is the only QMS system built specifically for the medical device industry. Non-industry specific QMS systems exist; however, they often have to be heavily modified to handle even the most mundane tasks in the medical device industry. As a result, Greenlight Guru helps device manufacturers spend more time on their product, and less time on paperwork.

How your company differentiates itself from the competition and what differentiates Greenlight Guru?

Greenlight Guru consists of three systems meant to help device manufacturers “GO” to market, “GROW” in the market, and “GURU” to provide regulatory expertise to device makers. This three pronged approach helps manufacturers through the full life-cycle of the product.

Business model

Greenlight Guru has a B2B business model with systems mean to help device makers “GO” to market, “GROW” in the market and “GURUs” to help stay in the market.

Current needs

Greenlight Guru is always looking for talented individuals with a willingness to work hard and improve the quality of life for our users.

When founded

2013

Number of full-time employees

45

Headquarters

Indianapolis, Indiana