The 50% of survey respondents who admitted their Quality System was still paper based, may be interested in new cloud-based quality management software exclusively for the medical device community.
The greenlight.guru software was designed for the unique regulatory and compliance aspects of bringing a medical device to market. It provides device makers with what the company claims is a “single source of truth” by integrating the management of design controls, controlled documents, quality processes and more in one, easy to use platform. The result allows medical device manufactures to bring new products to market faster while reducing risk by providing them a integrated quality system that is easy to use and designed for regulatory compliance.
greenlight.guru released its alpha version to a small group of early adopters in March of 2014, with subsequent release of the Beta version in November 2014, It seems feedback was good from the selected emerging and mid-stage medical device companies, which according to industry statistics, represent more than 80% of the US medical device companies, under an annual SaaS subscription model.
The company has now announced the public release of its system.
Greg Sommer, CEO & Co-founder of Sandstone Diagnostics Inc., a customer of greenlight.guru – “Using the greenlight.guru system has enabled us to better implement our quality system across the company and accelerate our product development.”
Jesseca Lyons, Product Development Engineer at Catheter Research Inc., stated, “greenlight.guru makes it much easier to organize everything I need for medical device product development. It’s great being able to quickly and easily modify everything – especially user needs and inputs. The best part is that every time requirements are modified or changed, it takes little effort on my part to maintain traceability.”
CEO and co-founder, Dave DeRam shared feedback from a recent call, “To have a single source of truth for making design decisions and standing up to an FDA audit is a game changer within the industry.” He continued, “Our customers recognize getting products to market with less risk, more features, ahead of the competition and with better patient outcomes is key to capturing market share.”
Jason McKibbin, greenlight.guru’s COO explains, “The single biggest risk a medical device company faces is the FDA. Now that we’ve set course to change the way the industry thinks about bringing products to market, we’re going to help them significantly lower that risk.”