Greenlight Guru

Founded in 2013, we provide cloud-based Quality Management System (QMS) and Electronic Data Capture (EDC) solutions for the MedTech industry. Our MedTech Suite helps medical device companies bring products to market efficiently and with less risk. We offer quality management, product development, and clinical data management solutions, along with training and education on industry regulations.

Our software’s key features include digital management of Design History Files (DHF) with built-in traceability, AI-powered suggestions, and predictive verifiability checks for design and development. For compliance and risk management, it tracks operational risk, regulatory requirements, audit readiness, and CAPA trends. We offer centralized control for documents, changes, and training, with automated routing, audit trails, and role-based access. Our system logs, tracks, and resolves quality processes and events, linking them to CAPAs, training, and documentation. Our platform also supports compliant, audit-ready clinical data capture across all study phases, from first-in-human to post-market.

In 2022, we acquired SMART-TRIAL, an Electronic Data Capture solution provider, and Vertex Intelligence, a data consultancy focused on integrating AI. We serve over 1,100 medical device companies, helping them maintain compliance with standards like ISO 13485, ISO 14971, FDA 21 CFR Part 820, and FDA 21 CFR Part 11. Our specialties include medical devices, design control, regulatory compliance, risk management, document control, post-market surveillance, and clinical data management.

Our mission is to improve the quality of life for our customers and their patients. We do this by addressing challenges faced by medical device companies with our solutions, industry expertise, and a peer community.

Our core values, summarized by C.A.R.E., guide our operations:

• Customer-Centric (Internal & External): We build trust by understanding customer needs, prioritizing quality, reliability, and empathy to deliver exceptional value and foster long-term relationships.
• Adaptive Learning: We continuously improve through open feedback, staying current with technologies and market trends, fostering growth and innovation through curiosity and shared knowledge.
• Responsible Risk-Taking: We embrace well-reasoned risks, recognizing that growth comes from both successes and failures. We promote action, balancing boldness with thoughtful decision-making.
• Execution (Drive Your Results): We take ownership of goals and outcomes, setting clear, measurable targets to achieve meaningful results. We encourage initiative, determination, and collaboration to overcome obstacles and foster accountability.

We operate as a remote-first organization with 201-500 employees. Our culture is human-centered. We prioritize trust and empathy in all interactions, aiming to deliver value to both our customers and team members. We foster an environment of continuous learning, responsible risk-taking, and a relentless drive for results, fueled by curiosity, adaptability, and accountability. This approach helps us create lasting relationships, encourage innovation, and empower team members to achieve success.

Our leadership team includes CEO Ed Holmes, CTO Brian Gaffney, CMO Natalia Dykyj, CSO Gene Gainey, and CFO Adam Feinzig, all with experience in software and SaaS. We emphasize that the work we do has a direct impact on people’s lives by helping medical device companies bring life-changing technologies to market.

We provide a comprehensive benefits package to support our remote-first workforce. This includes medical, vision, and dental insurance, as well as FSA and HSA options. We offer a 401k plan with a company match to support future savings. Employees get flexible Paid Time Off (PTO), which includes all major holidays, and flexible working hours to promote work-life balance.

To support remote work, we provide a home office stipend upon hire. We also offer paid parental leave, including three months of paid maternity leave, and a professional development stipend for career growth. Depending on the role and tenure, employees may be eligible for an Equity Program and incentive compensation. Disability insurance is also part of our benefits package.