Integrated and Compliant Risk Management
Greenlight Guru offers a comprehensive Risk Management workspace that simplifies the auditing process while ensuring full traceability within your Quality Management System (QMS). By seamlessly integrating risk-based thinking across your device ecosystem, Greenlight Guru facilitates effortless compliance with stringent standards like ISO 14971:2019 and ISO 13485:2016. This integrated approach not only streamlines the risk management process but also enhances overall compliance and quality management within your organization.
Benefits for Teams
Greenlight Guru's solution is designed to cater to the diverse needs of different teams within your organization. For product teams, the platform helps improve the quality, safety, and effectiveness of medical devices by establishing clear connections between design controls and risk management. This ensures a structured, risk-based approach to design that is fully traceable to related components and controls. Quality teams benefit from a holistic and well-documented risk management process that ensures compliance with industry standards and regulatory requirements. Leaders are empowered to allocate appropriate resources for conducting risk management activities, proactively managing risk to bring safer devices to market, and defining the company's risk management policy and acceptability criteria.
About Greenlight Guru
At Greenlight Guru, our mission is to provide efficient and compliant solutions for medical device companies. We are dedicated to empowering organizations in the medical technology sector to navigate complex regulatory landscapes and bring innovative products to market with confidence. With a focus on trust, security, and continuous support, we aim to be the partner of choice for companies looking to streamline their quality processes and ensure compliance at every stage of the product lifecycle. Our commitment to excellence is reflected in the range of solutions we offer, from risk management and quality control to document management, design control, and beyond.