Greenlight Guru
Greenlight Guru is dedicated to improving the quality of life for patients and customers by providing innovative software solutions tailored for the medical device industry. Their mission is to help MedTech companies navigate the complexities of product development, regulatory compliance, and quality management, ultimately accelerating the delivery of life-changing technologies to market. With a commitment to quality and security, Greenlight Guru is ISO 9001 and ISO 27001 certified, ensuring high standards in their operations.
Industries
Nr. of Employees
medium (51-250)
Greenlight Guru
Indianapolis, Indiana, United States, North America
Products
Cloud electronic QMS platform for medical devices
Cloud-based electronic QMS platform designed for device lifecycle management to support document control, design controls, risk management, CAPA, training and audit readiness.
Clinical EDC platform for medical device studies
Electronic data capture platform for device-focused pre-market and post-market studies supporting customizable forms, ePRO/eCOA collection, PMCF surveys and study templates.
AI/ML-enabled risk management and traceability module
Software module applying machine learning to support risk identification, change management recommendations and closed-loop traceability across quality and product development data.
Cloud electronic QMS platform for medical devices
Cloud-based electronic QMS platform designed for device lifecycle management to support document control, design controls, risk management, CAPA, training and audit readiness.
Clinical EDC platform for medical device studies
Electronic data capture platform for device-focused pre-market and post-market studies supporting customizable forms, ePRO/eCOA collection, PMCF surveys and study templates.
AI/ML-enabled risk management and traceability module
Software module applying machine learning to support risk identification, change management recommendations and closed-loop traceability across quality and product development data.
Services
QMS and Clinical Implementation Consulting
Advisory and implementation engagements including system configuration, design control and risk reviews, process automation, validation planning and audit preparation delivered by medical device subject-matter experts.
Software validation support and validation artifact packages
Risk-based validation artifacts, automated test outputs and templates provided to support customer validation activities and reduce validation workload for regulated software systems.
Training, webinars and podcast series
Live and on-demand webinars, podcast episodes and online courses covering clinical study design, regulatory strategy, standards compliance, design controls, CAPA, post-market surveillance, human factors, FDA submission pathways (510(k), De Novo, PMA, pre-submission), UDI and other regulatory topics.
Partner program enablement and integrations
Partner onboarding, technical partnership programs and integration toolkits to enable consultancies, CROs and technology vendors to deliver complementary services and integrations.
Technical support and customer success
Application support, knowledge base resources and customer success engagements for onboarding, troubleshooting and sustained platform adoption.
QMS and Clinical Implementation Consulting
Advisory and implementation engagements including system configuration, design control and risk reviews, process automation, validation planning and audit preparation delivered by medical device subject-matter experts.
Software validation support and validation artifact packages
Risk-based validation artifacts, automated test outputs and templates provided to support customer validation activities and reduce validation workload for regulated software systems.
Training, webinars and podcast series
Live and on-demand webinars, podcast episodes and online courses covering clinical study design, regulatory strategy, standards compliance, design controls, CAPA, post-market surveillance, human factors, FDA submission pathways (510(k), De Novo, PMA, pre-submission), UDI and other regulatory topics.
Partner program enablement and integrations
Partner onboarding, technical partnership programs and integration toolkits to enable consultancies, CROs and technology vendors to deliver complementary services and integrations.
Technical support and customer success
Application support, knowledge base resources and customer success engagements for onboarding, troubleshooting and sustained platform adoption.
Expertise Areas
- Quality management systems (QMS) for medical devices
- Clinical data capture and clinical study setup for medical devices and IVDs
- Regulatory compliance and submission readiness (FDA, ISO, EU MDR/IVDR, IEC standards)
- Risk-based software validation and computerized system assurance
Key Technologies
- Cloud-based SaaS electronic QMS
- Electronic data capture (EDC)
- Customizable electronic case report forms (eCRF)
- ePRO / eCOA capture