3 mins read

Greenlight Guru: Advancing a Quality Management Solution by Implementing a Modular Approach 


Greenlight Guru

About the project

Greenlight Guru is an industry-leading cloud-based purpose-built platform for MedTech companies focused on bringing life-changing medical device products to market faster, more efficiently, and with less risk. They approached HTEC to engineer an independent, scalable, smarter, resilient, modern software and systems architecture that would enhance their existing medical device quality management software and accelerate their time-to-market.  


In many aspects, the COVID-19 influence on the medical device manufacturing sector was enormous, revealing previously unknown problem areas. With teams working remotely in isolation and the inability of regulatory affairs professionals to navigate the complexities of approving medical technologies quickly and safely, medical companies faced challenges with rapidly ideating, designing, manufacturing, and launching new medical devices.  

After identifying this challenge, Greenlight Guru embarked on a mission to develop a new, more efficient, innovative, modern smart architecture to support their existing quality management platform. This new software architecture would allow end-users to complete regulatory and compliance processes more quickly and would enable Greenlight Guru to stay ahead of the curve in an ever-evolving industry. 

The COVID-19 pandemic has presented the medical technology industry with unique challenges. The need for new diagnostics, therapeutics, and vaccines to be designed, developed, and deployed quickly has highlighted the importance of flexibility and agility in the regulatory process.

Miloš Cigoj,

Healthcare and Life Science Quality and Compliance Lead, HTEC Group


Greenlight Guru: Advancing Quality Management solution by implementing Modular Approach Risk management

The HTEC team leaned on their extensive experience in the MedTech domain to evolve Greenlight Guru’s existing system by using the Strangler architecture pattern (putting an “old” system behind an intermediary interface) and implementing brand-new functionalities. By using this modular approach to software development, the HTEC team was positioned to develop enhanced capabilities that would empower end-users to complete regulatory and compliance processes faster and more efficiently. 

The first step was to make an independent risk management system module that allows end users to track and manage risks throughout the entire medical device product development life cycle. This improves device transparency, traceability, and inspection capabilities, resulting in much faster and less painful audit processes and a much better chance that patient safety won’t be adversely affected. 

Supported by HTEC’s deep expertise in reengineering legacy software platforms, the team managed to give this existing product a second life and made it future-proof without requiring fundamental changes to the system or compromising its market presence or quality. 

Our mission is to move MedTech forward by enabling medical device companies to innovate, build and launch products with the highest level of reliability, safety, and quality. The partnership between HTEC Group and Greenlight Guru presents an avenue for elevating medical device quality management and access to MedTech-specific software solutions meticulously designed to improve speed and quality while lowering risk and cost.

– Pete Plotas 

VP, Global Alliances, Greenlight Guru


By developing a more scalable, smarter decoupled and resilient modern architecture we will help the client be more exposed on the market and always ready for new capabilities rollouts. This will further enable the client’s end-users (medical device manufacturers startups and enterprises) to keep on delivering products ensuring the highest safety, reliability and quality on top of supporting regulatory efforts and compliance performance.  

To learn more about risk management in the medical device product development lifecycle, dive into the following articles: 

Risk Management in the Medical Device Lifecycle: Discovery and Prototyping 

Risk Management in the Medical Device Lifecycle: Development and Testing 

To learn more about this collaboration, read HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies

Explore how HTEC is guiding the healthcare and life sciences sectors to a digitally empowered future here

Let’s take the first step together.