Greenlight Guru provides a software platform that digitizes paper-based processes for medical device companies, supporting regulatory submissions, design control, and risk management. The platform uses machine learning to flag documents that could be affected by proposed change orders, helping customers understand downstream effects. The company has seen increased interest driven by regulatory changes, remote work shifts, and strained supply chains. It currently serves more than 500 medical device customers, including Centese and Sandstone Diagnostics. Greenlight Guru plans to use new funding to add capabilities to its platform and expand its customer base. The company is headquartered in Indianapolis. Greenlight.guru provides a cloud-based quality management system (QMS) that digitizes compliance and document workflows for medical device developers. Its platform centralizes design development records, quality management, and FDA compliance forms to help companies respond faster to regulators, customers and collaborators. The company positions the product to streamline regulatory document provision in an industry that still relies heavily on paper-based quality systems. Greenlight.guru said it will use the $1.25M in funding to broaden engineering staff, accelerate product development, and add customers in support of a public launch. CEO and co-founder Dave DeRam said a single source of truth for design decisions and FDA audits reduces risk and speeds time to market, enabling customers to bring products to market with fewer risks and better patient outcomes.

Total raised

$121M

Funding rounds

2

Latest round

Equity

Latest activity

Jun 2021