In the fast-paced world of medical device development, efficiency, compliance, and quality are paramount. Meet Greenlight Guru, a revolutionary software solution that is transforming the way medical device companies navigate the complex landscape of regulatory requirements and product life cycles. Build software like Greenlight Guru to take your medical business one step ahead in this competitive world.

With a comprehensive suite of tools and features, Greenlight Guru streamlines the entire product development process, from initial design to post-market surveillance. This innovative software empowers teams to efficiently manage design controls, risk management, document control, and regulatory submissions, ensuring adherence to industry standards and regulations.

By centralizing data and collaboration, Greenlight Guru fosters cross-functional teamwork, enhancing communication and traceability. Its intuitive interface and user-friendly dashboards enable seamless project management, fostering efficiency and productivity throughout the organization.

In this blog post, we delve deeper into the different aspects of Greenlight Guru.


Q1. What is Greenlight Guru Software? 

Greenlight Guru is a software platform specifically designed for the management of quality systems and regulatory compliance in the medical device industry. It provides a comprehensive solution for medical device companies to streamline and automate their quality management processes, ensuring compliance with regulatory standards and efficient product development.

With Greenlight Guru, medical device companies can establish and maintain a structured quality management system (QMS) that adheres to global regulatory requirements such as ISO 13485 and FDA regulations.

The software helps companies track and manage all quality-related activities, ensuring traceability, documentation control, and effective communication throughout product development and manufacturing processes.


Q2. How Does Greenlight Guru Software Work?

Greenlight Guru is a software platform designed to streamline and optimize the management of quality systems for medical device companies. It operates on a cloud-based model, providing a comprehensive solution for regulatory compliance and quality management.

The software guides users through the entire product lifecycle, from design control to risk management, document control, and validation. It offers a centralized repository for all relevant documents, enabling efficient collaboration and version control. Greenlight Guru facilitates the creation and management of quality plans, corrective and preventive actions (CAPAs), and non-conformance reports.

It also assists with audits and inspections, ensuring adherence to industry standards and regulations. With its intuitive interface and customizable workflows, Greenlight Guru simplifies and automates quality management processes, enabling medical device companies to enhance efficiency, reduce compliance risks, and accelerate time-to-market.


An annual industry benchmark study revealed that MedTech companies use on average nine different software tools for managing their processes, people, and data. With almost 40% of MedTech companies planning to increase their investments in software in 2023


Q3. What Are Some Amazing Facts About Greenlight Guru Software?

  • Greenlight Guru revenue is $21.0M annually. After extensive research and analysis, Zippia’s data science team found the following key financial metrics.
  • Greenlight Guru has 182 employees, and the revenue per employee ratio is $115,384.
  • Greenlight Guru peak revenue was $21.0M in 2022.
  • Greenlight Guru revenue is $21.0M annually. After extensive research and analysis, Zippia’s data science team found the following key financial metrics.
  • Greenlight Guru has 182 employees, and the revenue per employee ratio is $115,384.
  • Greenlight Guru peak revenue was $21.0M in 2022.


Q4. Why is Greenlight Guru Software So Popular?


  • Industry Focus:

Greenlight Guru is tailored specifically to the needs and requirements of the medical device industry. It understands the unique challenges faced by medical device companies in terms of regulatory compliance, quality management, and product development. By focusing solely on this industry, Greenlight Guru provides targeted solutions that address the specific pain points of medical device companies.


  • Regulatory Compliance:

The medical device industry is highly regulated, with stringent quality and regulatory standards to ensure patient safety. Greenlight Guru helps companies navigate these complex regulations by providing features and tools that streamline compliance processes. It offers automated workflows, document control, audit management, and other features that simplify regulatory compliance, saving time and effort for medical device companies.


  • Quality Management:

Quality is of paramount importance in the medical device industry, and Greenlight Guru helps companies maintain and improve product quality. It provides tools for managing design controls, risk management, nonconformances, and CAPA (Corrective and Preventive Actions) processes. These features help companies identify and address quality issues proactively, leading to better products and improved patient outcomes.


  • Collaboration and Traceability:

Greenlight Guru facilitates collaboration among different teams involved in medical device development and production. It provides a centralized platform where teams can collaborate on documents, share information, and track progress. This improves communication, reduces errors, and ensures traceability throughout the product life cycle.


Q5. What Are Some Alternatives to Greenlight Guru Software? 


  • MasterControl:

MasterControl is a comprehensive quality management system (QMS) that offers features specifically tailored for medical device companies. It provides end-to-end solutions for document control, training management, audit management, and CAPA (Corrective and Preventive Actions) processes. The software helps streamline compliance with FDA regulations and ISO standards, making it a popular choice for medical device manufacturers.


  • Pilgrim Quality Solutions:

Pilgrim Quality Solutions is a cloud-based QMS software that supports regulatory compliance and quality management across various industries, including medical devices. The platform offers modules for document control, change management, audit management, and supplier quality management. It also provides real-time analytics and reporting capabilities to track and improve quality metrics.


  • EtQ Reliance:

EtQ Reliance is a flexible and scalable QMS software suitable for medical device manufacturers. It offers a wide range of modules, including document control, risk management, training management, and complaint handling. The software allows companies to automate quality processes, monitor compliance, and streamline their overall quality management efforts.


  • AssurX:

AssurX is a cloud-based QMS software designed to help companies manage quality and compliance across multiple industries, including medical devices. The platform offers modules for document control, change management, nonconformance management, and corrective and preventive actions. AssurX also provides robust analytics and reporting features for monitoring quality performance and identifying areas for improvement.

  • Sparta Systems

TrackWise: Sparta Systems TrackWise is a widely used QMS software that caters to the needs of medical device manufacturers. The software offers modules for quality event management, corrective and preventive actions, supplier quality management, and regulatory compliance. TrackWise enables companies to automate their quality processes, track issues, and ensure compliance with industry regulations.

Build Software Like Greenlight Guru


Q6. What is the Pricing of Greenlight Guru Software?

Greenlight Guru has a starting price of $600 per user each month. Packages are charged per user under the pricing structure. There isn’t a risk-free trial offered. There is no accessible free version.


The global QMS software market is expected to reach $17.2 billion by 2025.


Q7. What Are the Advantages of Greenlight Guru Software?


  • Regulatory Compliance:

Greenlight Guru helps companies ensure compliance with various regulatory standards, such as FDA’s 21 CFR Part 820 and ISO 13485. It provides a structured framework to manage and document quality processes, facilitating audits and regulatory submissions.


  • Quality Management System (QMS) Integration:

The software integrates all aspects of a company’s quality management system into a single platform. It enables efficient management of documents, design controls, risk management, training records, and other quality-related processes.


  • Collaboration and Traceability:

Greenlight Guru facilitates collaboration among cross-functional teams, allowing them to work together on design changes, risk assessments, and other quality activities. The software maintains a comprehensive audit trail, ensuring the traceability of decisions and actions throughout the product lifecycle.


  • Design Controls and Risk Management:

It offers robust features for managing design controls and risk management processes. Companies can effectively capture design inputs, manage design changes, conduct risk assessments, and track verification and validation activities.


  • Document Control and Change Management:

Greenlight Guru provides a centralized repository for managing documents, ensuring version control, and maintaining a history of changes. It streamlines the change management process, making it easier to review, approve, and implement document revisions.


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Q8. What Are the Features of Greenlight Guru Software?


  • Design Controls:

The software supports the management of design and development processes, helping companies establish and maintain design control procedures. It assists with requirements management, risk management, design verification and validation, and traceability.


  • Risk Management:

Greenlight Guru enables effective risk management by providing tools to identify, assess, and mitigate risks associated with medical device development and manufacturing. It supports risk analysis, risk assessment, and risk control activities in accordance with industry standards such as ISO 14971.


  • Change Management:

The software helps organizations manage and track changes to their medical devices and associated documentation. It facilitates change requests, impact analysis, and change implementation processes, ensuring proper documentation and traceability throughout.


  • Complaints and Nonconformance:

Greenlight Guru offers features for managing customer complaints and nonconformance events. It allows users to log, investigate, and resolve complaints, as well as track and manage nonconforming products and associated corrective and preventive actions (CAPAs).


  • Supplier Management:

The software enables effective supplier management by providing tools to assess and qualify suppliers, manage supplier documentation, and track supplier performance. It helps ensure that only approved suppliers are used and facilitates communication and collaboration with suppliers.


Q9. What Are the Disadvantages of Greenlight Guru Software?


  • Cost:

Greenlight Guru can be relatively expensive compared to other QMS software options, especially for smaller or startup medical device companies with limited budgets. The pricing structure may not be suitable for all organizations, particularly those with tighter financial constraints.


  • Learning Curve:

Transitioning to a new QMS software, including Greenlight Guru, can involve a learning curve for users who are accustomed to a different system or are new to QMS implementation. The complexity of the software and the need for proper training can make the initial adoption process challenging.


  • Customization Limitations:

While Greenlight Guru provides a comprehensive set of features for managing quality systems, there may be limitations when it comes to customization. Some users may find that the software doesn’t perfectly align with their specific processes or requirements, and they may need to adapt their workflows to fit within the platform’s framework.


  • Integration Challenges:

Integrating Greenlight Guru with existing systems or software used within the organization may present challenges. Depending on the organization’s IT infrastructure and requirements, it may require additional effort and resources to ensure smooth data exchange and interoperability between Greenlight Guru and other systems.


  • Dependency on Internet Connection:

As a cloud-based solution, Greenlight Guru relies on a stable internet connection for access and functionality. This dependency on internet connectivity means that any disruptions or outages may temporarily hinder users’ ability to access and utilize the software effectively.


Q10. How Much Does it Cost to Build Software Like Greenlight Guru? 

The cost of building software like Greenlight Guru can vary significantly depending on various factors. It is important to consider aspects such as the complexity of the software, the desired features and functionalities, the development team’s experience and rates, the technology stack used, and the overall project scope.

To provide a general estimate, building a comprehensive quality management software similar to Greenlight Guru can range from $25000-$50000. This cost includes activities such as requirement gathering, software design, development, testing, deployment, and ongoing maintenance.

However, it’s essential to note that this estimate is subjective and can differ based on individual project requirements and market rates. Additionally, ongoing expenses like server hosting, infrastructure, and customer support should be considered for a complete cost assessment.

To obtain a more accurate estimate, it is recommended to consult with a software development company or hire a team of experienced developers who can analyze your specific needs and provide a tailored cost estimate for building software similar to Greenlight Guru.