Greenlight Guru

Greenlight Guru provides quality management system (QMS) and clinical data capture software specifically designed for medical device companies. Founded in 2006 by Jon Speer and David DeRam, the company addresses the inefficiencies of paper-based quality systems and generic QMS solutions that weren't built for the unique requirements of medical device development and regulatory compliance.

The platform offers integrated design controls with digital design history file (DHF) management, risk management capabilities, document and training control, quality event tracking, and clinical trial data management. The system features AI-powered suggestions, predictive verifiability checks, and built-in traceability across design inputs, outputs, verifications, and product risk controls. In 2022, Greenlight Guru acquired SMART-TRIAL to strengthen its clinical data capture capabilities and Vertex Intelligence to integrate AI functionality across its solutions.

The company serves over 1,100 medical device manufacturers globally, ranging from startups developing their first device to established companies managing product portfolios. Greenlight Guru supplements its software platform with educational resources including a podcast with 300,000+ listeners and a widely-read industry blog.

Organizations should consider Greenlight Guru when they need a quality management system built specifically for medical device regulatory requirements rather than adapting a generic QMS. The platform's integrated approach to design controls, risk management, and clinical data capture eliminates the need for multiple disconnected systems.

Companies can expect guided implementation with medical device industry expertise, AI-assisted compliance workflows that reduce manual effort, and a system designed to scale from first device development through portfolio management. The platform is particularly valuable for teams seeking to improve efficiency in FDA submissions, audit preparation, and maintaining quality culture throughout the device lifecycle.

Greenlight Guru serves exclusively the medical device and diagnostic sectors of healthcare, with deep specialization in FDA, ISO 13485, and international medical device regulatory frameworks. The platform addresses compliance requirements specific to medical device development including design controls per 21 CFR Part 820, risk management per ISO 14971, and clinical investigation requirements.

The company serves medical device manufacturers, in vitro diagnostic developers, Software as a Medical Device companies, medical device contract research organizations, and laboratory developed test providers. Their clinical data capture capabilities support compliant data collection from first-in-human studies through post-market surveillance, addressing the complete medical device lifecycle within healthcare delivery.

The ideal client is a medical device manufacturer, IVD company, or SaMD developer that needs regulatory-compliant quality management throughout the product lifecycle. This includes venture-backed startups preparing for first regulatory submissions, growing companies scaling from single to multiple products, and established manufacturers seeking to modernize quality systems. Organizations benefit most when they have dedicated quality or regulatory personnel ready to implement a specialized QMS rather than using generic quality tools.