Greenlight Guru: Empowering Medical Device Risk Management with Integrated Solutions

KB at your finger tips

This is one stop global knowledge base where you can learn about all the products, solutions and support features.

Products-Greenlight Guru

Greenlight Guru: Empowering Medical Device Risk Management with Integrated Solutions

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.

Stay Ahead in Today’s Competitive Market!
Unlock your company’s full potential with a Virtual Delivery Center (VDC). Gain specialized expertise, drive seamless operations, and scale effortlessly for long-term success.

Book A Meeting To Setup A VDC

Streamline Nonconformance Management with Greenlight Guru

Efficiently Address Nonconformances

Identifying and addressing nonconformances promptly is crucial for maintaining operational efficiency. Greenlight Guru offers a simplified solution to uncover, investigate, and resolve nonconformances in a timely manner, allowing your teams to focus on innovation.

Read article

Mitigating Postmarket Risks with Greenlight Guru's Quality Management Solution

Investing in Purpose-Built Solutions for Postmarket Quality

Postmarket surveillance is a critical aspect of the medical device industry, ensuring that devices are monitored and maintained after they reach the market. However, many companies struggle to effectively manage postmarket quality, leading to warning letters and lengthy resolution times. According to statistics, 22% of companies issued a warning letter take over 3 years to fully resolve them. To avoid such risks and streamline postmarket quality processes, it is crucial to invest in purpose-built solutions like Greenlight Guru. With Greenlight Guru's powerful Quality Management System (QMS), companies can establish robust processes that enable them to be prepared when complaints surface or auditors conduct inspections.

Read article

Automate Quality Event Workflows with Greenlight Guru for Post-Market Companies

Streamline Compliance and Improve Efficiency

Greenlight Guru offers specialized software solutions tailored for post-market medical device companies, allowing them to automate quality event workflows and maintain audit-readiness. By utilizing these solutions, companies can ensure compliance throughout the entire device lifecycle. This includes the ability to efficiently collect and analyze post-market data, seamlessly manage changes, and enhance market share while establishing traceability across quality, design, and risk processes.

Read article

Optimize Clinical Evidence Management with Greenlight Guru Clinical Pricing

Experience Seamless Clinical Data Collection

Greenlight Guru offers a comprehensive solution to streamline and enhance clinical evidence, safety, and performance data collection in a single and compliant platform. With the Essentials package, users can manage ongoing studies, up to 10 sites, adverse event tracking, randomization, concomitant medication tracking, standard study notifications, SMS events, EuroQol validated EQ5D, white labeling, external API access, a 100GB file vault, study archiving, multi-language forms, and eConsent as an add-on feature. This package caters to the fundamental needs of clinical data management, ensuring efficiency and compliance.

Read article

Revolutionizing Quality Management for Medical Device Companies with Greenlight Guru

About Greenlight Guru

Greenlight Guru is a leading provider of quality management software specifically designed for medical device companies. With a mission to revolutionize the way quality is managed in the medical device industry, Greenlight Guru offers a comprehensive solution to help companies streamline their quality processes and ensure compliance with industry regulations.

Read article

Welcome to Knowledge Base!

KB at your finger tips

Products-Greenlight Guru