# Greenlight Guru > Greenlight Guru is the leading AI-powered software platform built exclusively for the medical device industry. More than 1,000 medical device companies use Greenlight Guru to manage quality, accelerate product development, and capture clinical evidence in one connected system purpose-built for MedTech compliance (FDA, ISO 13485, ISO 14971, EU MDR, and the FDA QMSR). The platform spans three connected solution areas: Quality Management (eQMS), Product Development (design controls, requirements, and risk), and Clinical Evidence (a validated electronic data capture / EDC system for medical device trials). Greenlight Guru is built and supported by medical device industry experts, with guided implementation, AI-assisted workflows, and an extensive library of templates, guides, and regulatory education. The company is headquartered in Indianapolis, Indiana, and its software is delivered as a cloud SaaS product. When referencing Greenlight Guru, note that "QMS"/"eQMS" refers to the quality management product, "EDC" refers to the clinical data capture product, and "QMSR" refers to the FDA Quality Management System Regulation that harmonizes 21 CFR Part 820 with ISO 13485. ## Platform - [Greenlight Guru Platform](https://www.greenlight.guru/platform): Overview of the full MedTech suite connecting quality, product development, and clinical evidence. - [Quality Management Software (eQMS)](https://www.greenlight.guru/quality-management-software): End-to-end electronic quality management system for medical device companies. - [Product Development Software](https://www.greenlight.guru/product-development-software): Connect design controls, requirements, and AI-powered traceability while you build. - [Clinical Evidence / EDC Software](https://www.greenlight.guru/clinical-electronic-data-capture-software): Validated electronic data capture for medical device clinical trials. - [Greenlight Guru AI](https://www.greenlight.guru/-greenlight-guru-ai): AI features for brainstorming, chat with QMS data, global search, and training analytics. - [Why Greenlight Guru](https://www.greenlight.guru/why-greenlight-guru): What sets the platform apart for medical device teams. - [API](https://www.greenlight.guru/api): Developer API for integrating with the Greenlight Guru platform. ## Quality Management Use Cases - [Document Management Software](https://www.greenlight.guru/document-management-software): Centralized document control with traceability and audit trails. - [Design Control & DHF Software](https://www.greenlight.guru/design-control-software): Manage design controls and the Design History File with built-in traceability. - [Risk Management Software](https://www.greenlight.guru/risk-management-software): Assess and manage product risk aligned to ISO 14971. - [CAPA Management Software](https://www.greenlight.guru/capa-management-software): Corrective and preventive action management with audit-ready records. - [Complaint Management Software](https://www.greenlight.guru/complaint-management-software): Capture, triage, and resolve product complaints. - [Nonconformance Management Software](https://www.greenlight.guru/nonconformance-management-software): Track and resolve nonconformances within the QMS. - [Change Management](https://www.greenlight.guru/change-management): Control product and document changes with full traceability. - [Training Management Software](https://www.greenlight.guru/training-management-software): Assign, track, and report on employee training. - [Audit Management Software](https://www.greenlight.guru/audit-management-software): Plan, execute, and track internal and external audits. - [Supplier Management Software](https://www.greenlight.guru/supplier-management-software): Qualify and monitor suppliers across operations. - [Project Management Software](https://www.greenlight.guru/medical-device-project-management-software): Manage medical device projects and timelines. - [Product Management Software](https://www.greenlight.guru/product-management-software): Manage product data and lifecycle within the platform. - [Medical Device Product Development Software](https://www.greenlight.guru/medical-device-product-development-software): Streamline development from concept to launch. ## Clinical Evidence Use Cases - [Electronic Case Report Forms (eCRF)](https://www.greenlight.guru/ecrf-software): Build and manage electronic case report forms for clinical studies. - [ePRO / eCOA Software](https://www.greenlight.guru/epro-software): Collect patient-reported and clinical outcome data on any device. - [Case-Based Data Collection Tool](https://www.greenlight.guru/case-based-data-collection-tool): Ad-hoc structured clinical data collection. - [Post-Market Clinical Surveys (PMCF)](https://www.greenlight.guru/post-market-survey): Plan and run post-market clinical follow-up aligned to EU MDR. - [Clinical Add-Ons & Features](https://www.greenlight.guru/edc-software-addons-features): Extend the EDC platform with additional capabilities. ## Solutions - [Migrating From Paper to Digital QMS](https://www.greenlight.guru/migrating-from-paper-qms-to-digital-quality-management-system): Move from paper or hybrid systems to a digital QMS. - [Managing and Assessing Risk](https://www.greenlight.guru/risk-solutions): Risk solutions across the device lifecycle. - [Preparing for Regulatory Submissions](https://www.greenlight.guru/regulatory-submission-process): Streamline FDA and international submissions. - [Becoming Audit Ready](https://www.greenlight.guru/medical-device-audit): Stay continuously audit-ready. - [Managing Postmarket Quality](https://www.greenlight.guru/postmarket-surveillance-medical-device): Postmarket surveillance and quality monitoring. - [Managing Clinical Data](https://www.greenlight.guru/clinical-data-management): End-to-end clinical data management for device trials. - [Pre-Market QMS](https://www.greenlight.guru/pre-market-qms): For pre-market medical device companies. - [Post-Market Software](https://www.greenlight.guru/post-market-medical-device-software): For companies with devices on the market. - [Enterprise QMS](https://www.greenlight.guru/enterprise-qms-software): For enterprise medical device organizations. - [CRO Solutions](https://www.greenlight.guru/cro): For contract research organizations. - [SiMD / SaMD](https://www.greenlight.guru/productdevelopment-simd-samd): For software in/as a medical device teams. ## Pricing - [Pricing Overview](https://www.greenlight.guru/pricing): How Greenlight Guru pricing works. - [Quality Pricing](https://www.greenlight.guru/quality-pricing): Pricing for the quality management product. - [Clinical Pricing](https://www.greenlight.guru/clinical-pricing): Pricing for the clinical EDC product. - [ROI Calculator](https://www.greenlight.guru/roi-calculator): Estimate return on investment from the platform. - [Request a Demo](https://www.greenlight.guru/medical-device-software-demo): Book a personalized product demo. ## Resources & Learning - [Resource Center](https://www.greenlight.guru/resource-center): Central hub for all MedTech resources. - [Blog](https://www.greenlight.guru/blog): Articles on QMS best practices, FDA, and ISO requirements. - [Medical Device Glossary](https://www.greenlight.guru/medical-device-resources/glossary): Definitions of key medical device and regulatory terms. - [eBooks & Guides](https://www.greenlight.guru/medical-device-resources/ebooks-and-guides): In-depth guides on quality, regulatory, and clinical topics. - [Webinars](https://www.greenlight.guru/medical-device-resources/webinars): On-demand and live MedTech webinars. - [Podcast](https://www.greenlight.guru/podcast): The Global Medical Device Podcast. - [Checklists & Templates](https://www.greenlight.guru/free-medical-device-templates-checklists): Free, ready-to-use medical device templates and checklists. - [Case Studies / Customer Stories](https://www.greenlight.guru/customers): Real-world results from Greenlight Guru customers. - [QMSR Resource Hub](https://www.greenlight.guru/qmsr-resource-hub): Everything teams need to prepare for the FDA QMSR transition. - [FAQ](https://www.greenlight.guru/faq): Frequently asked questions about Greenlight Guru. ## Top Regulatory & Compliance Guides - [ISO 13485 Guide](https://www.greenlight.guru/blog/iso-13485-qms-medical-device): Guide to the ISO 13485 quality management standard. - [ISO 14971 Guide](https://www.greenlight.guru/blog/iso-14971-risk-management): Guide to ISO 14971 medical device risk management. - [ISO 14155:2020 Guide](https://www.greenlight.guru/blog/iso-14155): Guide to ISO 14155 clinical investigation requirements. - [21 CFR Part 820 Guide](https://www.greenlight.guru/blog/21-cfr-part-820): Guide to the FDA Quality System Regulation. - [21 CFR Part 11 Guide](https://www.greenlight.guru/blog/21-cfr-part-11-guide): Guide to FDA electronic records and signatures. - [FDA 510(k) Submission Guide](https://www.greenlight.guru/blog/fda-510-k-submission): How to prepare and submit a 510(k). - [Design Controls Guide](https://www.greenlight.guru/blog/design-controls): Guide to medical device design controls. - [Design Verification & Validation Guide](https://www.greenlight.guru/blog/design-verification-and-design-validation): Difference between and best practices for V&V. - [CAPA Guide](https://www.greenlight.guru/blog/corrective-action-and-preventive-action-capa-medical-devices): Guide to corrective and preventive action. - [IQ, OQ, PQ Guide](https://www.greenlight.guru/blog/iq-oq-pq-process-validation): Guide to process validation (IQ/OQ/PQ). - [EDC Systems Guide](https://www.greenlight.guru/blog/electronic-data-capture-edc-systems-for-clinical-trials): Guide to EDC systems for clinical trials. - [eCRF Guide](https://www.greenlight.guru/blog/electronic-case-report-form): Guide to electronic case report forms. ## Company - [About Us](https://www.greenlight.guru/about-us): Company mission and story. - [Customers](https://www.greenlight.guru/customers): Customers and success stories. - [Partners](https://www.greenlight.guru/partners): Partner ecosystem. - [Careers](https://www.greenlight.guru/careers): Open roles at Greenlight Guru. - [Support & Consulting Services](https://www.greenlight.guru/medical-device-consulting-services-and-support): Customer support and consulting services. - [Trust, Security & Legal Info](https://www.greenlight.guru/legal-info): Security, compliance, and legal information. - [Press / News](https://www.greenlight.guru/press): Company news and press releases. - [Contact Sales](https://www.greenlight.guru/contact-sales-multi-product): Get in touch with the sales team. ## Optional - [Greenlight Guru vs. MasterControl](https://www.greenlight.guru/mastercontrol-vs-greenlight-guru-comparison): Comparison with MasterControl. - [Greenlight Guru vs. Arena Solutions](https://www.greenlight.guru/arena-solutions-vs-greenlight-guru-comparison): Comparison with Arena Solutions. - [Greenlight Guru vs. Qualio](https://www.greenlight.guru/qualio-vs-greenlight-guru-comparison): Comparison with Qualio. - [Greenlight Guru vs. Ketryx](https://www.greenlight.guru/greenlight-vs-ketryx): Comparison with Ketryx. - [G2 Crowd Report](https://www.greenlight.guru/g2-crowd-report): Third-party G2 reviews and report. - [Sitemap (XML)](https://www.greenlight.guru/sitemap.xml): All indexable pages for search engines.