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Company description

Greenlight Guru is a purpose-built software platform serving 1,100+ medical device companies worldwide, combining AI-powered Quality Management System (QMS) and Electronic Data Capture (EDC) software to help medtech teams move faster, stay compliant, and grow with confidence. Founded on the observation that paper-based quality management systems are painful, risky, and inefficient, Greenlight Guru was developed to give medical device companies a modern, intuitive solution for bringing higher-quality, life-changing products to market more efficiently and with less risk.

The company was co-founded by Jon Speer, a medical device engineer turned consultant, and David DeRam, and has grown significantly over the years. In 2022, Greenlight Guru acquired SMART-TRIAL, a leading Electronic Data Capture solution provider, expanding its offering across the full medical device lifecycle. The company also acquired Vertex Intelligence, a data consultancy that has helped integrate AI capabilities across the Greenlight Guru platform. Today, the platform supports the entire medical device lifecycle — from pre-market development through post-market surveillance and clinical evidence generation.

Quality Management Modules

• Document Management: Control documents, training, and change processes in one place, with automated routing, audit trails, role-based access, and full traceability.
• Quality Events: Log, track, and resolve CAPAs, audits, and nonconformances in a connected system that links quality events to training and documentation, maintaining audit-ready records at all times.
• Suppliers & Operations: Qualify suppliers and manage parts with full visibility across the supply chain.
• Compliance and Risk Management: Track and manage operational risk across the QMS, from regulatory requirements to audit readiness and CAPA trend analysis.

Product Development Modules

• Requirements Management: Link customer needs, design requirements, and verification activities directly to design controls, enabling a fully traceable Design History File (DHF).
• Software Release Management: Automate traceability from development tools to accelerate software releases and maintain compliance for SiMD and SaMD products.
• Risk Management: Assess and manage ISO 14971 risk as requirements and tests evolve throughout the product development process, with AI-powered suggestions and predictive verifiability checks.

Clinical Evidence Modules

• Clinical Trials: Capture compliant, audit-ready clinical data across every phase of a study — from first-in-human to post-market — using a validated medical EDC system.
• PMCF (Post-Market Clinical Follow-Up): Plan and manage PMCF activities aligned to EU MDR expectations, with connected data, documents, and workflows.
• ePRO/eCOA: Collect clinical outcome data in-person or remotely on any device, supporting flexible and decentralized study designs.

Core Platform Capabilities

• AI, Data, and Intelligence: AI-powered tools help teams find issues faster, make smarter decisions, and reduce manual work across quality and development workflows.
• Built-in Traceability: The platform digitally manages the DHF with built-in traceability between design inputs, outputs, verifications, and product risk controls.
• Guided Implementation: Personalized implementation plans are designed to deliver measurable time-to-value in weeks, not months or years.
• Scalability: Whether developing a first device or managing a full portfolio on the market, the platform is designed to support companies at every stage of growth.

Who Greenlight Guru Serves

• Pre-market and post-market medical device companies
• Contract Research Organizations (CROs)
• Enterprise medical device organizations
• Software-in/as a Medical Device (SiMD/SaMD) companies
• Functional teams including QA/RA, Product/R&D, Clinical, and Executive leadership
• Companies migrating from paper, preparing for regulatory submissions, managing risk, becoming audit-ready, or managing clinical data

Education, Thought Leadership, and Resources

• The Global Medical Device Podcast: The industry's most trusted and popular podcast, with more than 300,000 listeners.
• MedTech Blog: The leading medical device blog, read by over 200,000 people, covering industry news, trends, and best practices.
• Industry Academy: Access to the largest collection of premium MedTech educational content taught by leading industry experts.
• Templates, Checklists, and Webinars: A broad resource hub offering tools and content to help teams implement quickly and meet regulatory requirements.
• QMSR Hub: A dedicated resource to help companies understand what is changing with QMSR, what is at stake, and how to maintain compliance.

Greenlight Guru's mission is to improve the quality of life for its customers and their patients by solving challenges unique to medical device companies with innovative software and deep industry expertise. Trusted by more than 1,100 medical device companies around the world, the platform is purpose-built for medtech and backed by a team committed to helping the industry bring safer, higher-quality devices to market.

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Software attributed to Greenlight Guru

• QMSView
• Greenlight Guru ClinicalView

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