Greenlight Guru

Greenlight Guru offers a modern eQMS designed for product-led, fast-moving medtech innovators. Its flexible system adapts to your processes, allowing engineers to focus on product development rather than paperwork, while remaining audit-ready. The platform is built for engineers and trusted by auditors.

For established and expanding medtech teams, Greenlight Guru provides guardrails for guidance, global scalability, and audit-tested quality workflows. It also offers data collection and management solutions specifically for medtech clinical trials, featuring no-code setup for any study type, a single platform for all studies, and facilitating ISO 14155 and 21CFR Part 11 compliance.

Greenlight Guru combines intuitive software with deep industry expertise to help medical device companies grow efficiently and maintain audit readiness throughout the entire product lifecycle. It maximizes efficiency by driving improvements across quality, product development, and clinical affairs, enabling users to track quality events, find documents, maintain traceability, accelerate development with connected design control and risk workflows, and collect compliant clinical data.

Simplify compliance with confidence through audit-tested templates and workflows adhering to regulatory requirements. The system ensures audit readiness with a single, searchable platform maintaining traceability, supports ISO-14155 compliant clinical studies, and keeps teams compliant with role-based training.

Scale with confidence as Greenlight Guru supports growth by simplifying operations with dedicated workspaces for supplier management and training, enabling clinical data collection at any device stage, addressing problems with compliant CAPA and nonconformance workflows, and providing expert guidance.

Launch with confidence and accelerate submission timelines. Greenlight Guru enhances collaboration with a design controls workspace connected to the QMS, expedites reviews and approvals, supports building clinical investigations, and automates time-consuming tasks.

Key benefits include software built specifically for medical device needs, guided implementation for rapid time-to-value, and a scalable design to support companies at any stage of growth. Testimonials highlight its ease of use, effectiveness in audits, and significant time savings.