QMS

Greenlight Guru Quality Management Software (QMS) is a medtech-specific electronic quality management system (eQMS) designed to help medical device teams accelerate product development while maintaining full regulatory compliance. Unlike generic project management or eQMS tools, Greenlight Guru is purpose-built for the unique demands of the medical device industry, supporting design controls, risk management, software release lifecycle management, and traceability — all within a single, connected platform. It is trusted by more than 1,000 medical device companies, from pre-market startups to post-market enterprises, as well as SaMD and SiMD teams.

The platform addresses a critical challenge faced by 41% of medtech development teams: documenting new work during design controls. Greenlight Guru eliminates this friction by building compliance documentation in the background as teams work, keeping Product and Quality functions in sync without slowing down engineering velocity.

Design Controls and Design History File (DHF) Management

• Automatically builds the Design History File (DHF) as design controls are initiated, maintaining complete traceability throughout the system.
• Links design inputs, risks, and tests so traceability is established and maintained without manual effort.
• Enables teams to manage every stage of design controls, including user needs, design inputs, design outputs, verification, validation, and design reviews.
• Allows requirements, risks, and verifications to be connected without leaving the workspace or interrupting team workflows.
• AI-powered checks review requirements for verifiability, while real-time trace graphs expose missing links across design, risk, and test artifacts.
• Every element within the DHF is versioned, reviewable, and export-ready for audits and regulatory submissions.

Software Release Lifecycle Management

• Provides a unified view to manage every software release, reducing complexity for engineering teams.
• Allows teams to configure release forms, reference affected software parts, and tie code changes and pull requests to each release.
• Automatically syncs tests and documentation from developer tools such as GitHub, enabling engineers to continue working in the systems they already use.
• Designed specifically for the fast, iterative release cycles of SaMD and SiMD teams, with SDLC support and automation built in.

Risk Management

• Centralizes risk management, replacing scattered spreadsheets with a structured, connected system aligned to ISO 14971:2019.
• Enables teams to build risk matrices by defining types of risk, severity, and probability, all tied directly to design work.
• Allows design controls and documents to be related as risk control measures within the system.
• Maintains a dynamic, audit-ready Risk Management File (RMF) that updates as product decisions evolve.
• Keeps risk context current so teams always have a clear, up-to-date view as requirements and tests change.

Requirements Management

• Links user needs, requirements, and verification evidence directly to design controls for end-to-end traceability.
• AI features help identify gaps in requirements and suggest connections to reduce manual review work.
• Maintains clarity as teams grow, products mature, or ownership changes over time.

Audit and Submission Readiness

• Generates traceability matrices, complete Design History Files, and Risk Management Files for audits and regulatory submissions.
• Supports export of Medical Device Files (MDF), Device Design Files (DDF), and full audit trails.
• Workflows are designed in accordance with ISO 13485:2016 and the FDA's Quality Management System Regulation (QMSR), providing a compliant path from development through submission and post-market surveillance.

Developer Integrations and Engineering-Friendly Design

• Integrates natively with GitHub and Jira to provide effortless traceability without changing how engineering teams work.
• Includes an extensive suite of flexible APIs for broader workflow connectivity.
• Every screen and workflow is designed with speed, clarity, and usability in mind to encourage team adoption.
• Built-in AI features reveal gaps, suggest connections, and reduce manual work while keeping humans in control of decisions.

Implementation and Onboarding

• A dedicated Onboarding and Implementation team works with each customer to create a custom implementation plan.
• Supports phased migration of data and documentation from spreadsheets or paper-based systems, allowing teams to begin working in the platform immediately.
• Configurable to meet existing workflows without introducing compliance risk.
• Personalized onboarding and on-demand assistance are available from Greenlight Guru's medtech expert support team.

Greenlight Guru's product development software is designed in accordance with a broad range of industry standards, including ISO 13485, ISO 14971, IEC 62304, IEC 60601, ISO 10993, and others. The platform is suitable for pre-market and post-market organizations, CROs, enterprises, and teams building software-enabled devices, and connects seamlessly with Greenlight Guru's broader platform capabilities covering quality management and clinical evidence management.