Greenlight Guru

Greenlight Guru is a software platform built for medical device companies, combining three main areas: quality management (eQMS), product development, and electronic data capture for clinical trials. The quality module covers documents, training, CAPAs, and audit trails. Product development focuses on design controls and traceability across design inputs, outputs, verifications, and risk controls. The clinical module supports data capture across study phases. The vendor's site also describes AI features layered across these modules, including an AI chat for querying QMS data, AI-assisted brainstorming for design controls and risk, AI-powered search with linked source references, and training analytics that answer plain-language questions with charts.

The vendor states the platform is built specifically for medical device companies, aligning with standards such as ISO 13485, ISO 14971, IEC 60601, and IEC 62304, and supporting 21 CFR Part 11 compliance. The site describes the platform as serving companies of varying size and stage, from first device to a full portfolio, but does not give specific employee-count or revenue thresholds for its target customer. The site does not state how the software is deployed (cloud, on-premise, or hybrid).

Pricing is not published on the vendor's site. The pricing page asks visitors to select a solution and then view a package, or to talk to a Greenlight Guru representative; no dollar figures, tiers, or per-user rates are listed. The site also does not describe how the quality, product development, and clinical modules integrate with external tools such as ERP or PLM systems beyond stating that the product development tools integrate with unspecified "dev tools." Buyers evaluating the platform would need to contact sales directly to get pricing and confirm deployment and integration details.