HTD Health Chooses Greenlight Guru Quality for a Modern, SaMD-Friendly eQMS

HTD Health: On a mission to create a more human-centric, accessible, and productive healthcare system 

HTD Health is working to create a better healthcare system, one company at a time. As a consulting organization that also creates high-quality tools and products, HTD Health offers a broad range of services to MedTech companies working on software applications.  

Whether their clients are building companion applications for medical devices or software as a medical device (SaMD), if it has to do with producing the digital aspects of medical devices, HTD Health can help. By thoughtfully applying technology to the healthcare industry, the team at HTD Health hopes to support and extend the human potential in care delivery and improve patient experiences around the world. 

The Challenge: Finding an eQMS that was up to their standards

HTD Health is a software company working with clients who are building cutting edge digital health products. So it made no sense for them to be stuck using a paper QMS or a generic software solution that wasn’t built with MedTech in mind.

They needed an eQMS that was modern, user-friendly, and up to the standards of the products they help their clients build and take to market. 

So, they turned to Greenlight Guru.

The Solution: Greenlight Guru Quality

Greenlight Guru Quality is the #1 QMS software for MedTech companies, but it wasn’t the only option the HTD Health team considered.

As Zach Markin, Co-Founder and CEO of HTD Health, noted, the company did an enormous amount of research while they were choosing an eQMS, because they knew it was a decision they couldn’t afford to get wrong. 

“Our guiding principle was, what’s the tool that will let us go where we want to go as an organization? It’s possible to quickly put together a passable QMS, but that doesn’t necessarily mean it will be something that’s sustainable for the long run,” said Markin.

Markin and the team evaluated a few other QMS solutions that initially looked promising. But when they began asking difficult questions, the most thoughtful answers—and the right ones—only came from Greenlight Guru. 

“Generally, everyone says, ‘We can do this or we can check that box.’ But when you push a little more not everyone has a strong justification for saying that. Greenlight Guru did, and it made our choice very easy.”

The Results: Unbeatable compliance and greater confidence in delivering for clients

HTD Health uses the Agile methodology for software development. They didn’t want to lose the speed and adaptability of Agile, but they knew that staying compliant with the many regulatory requirements in MedTech was of the utmost importance.  

“We wanted a tool that was sufficiently flexible that we could bring out preferences and approach, but would still keep us from coloring outside the regulatory lines,” Markin said. 

With Greenlight Guru, HTD Health could continue using Agile, adapting the workflows to their needs while still meeting all of their regulatory requirements. 

“Within the workflows, we can ensure that each and every activity will be compliant with the regulations, which is great,” said Weronika Michaluk, SaMD Lead at HTD Health.

They also liked that Greenlight Guru Quality integrates with Jira. As a software company, they use Jira extensively, and needed an eQMS that could work well with the project management platform. 

Confidently helping clients with regulatory concerns

Like any consulting organization, HTD Health has to come through for their clients when they make a promise. It turns out, one of the benefits of having a modern, streamlined QMS is that it’s easier than ever to see where projects are at and show clients the results. 

“It’s important that we have clear systems for documenting what we’ve done and how we’ve fulfilled our promises to our clients,” Markin said. Having that documentation and visibility into the quality system helps HTD Health show their customers what they’ve delivered on. 

“It’s improved our confidence, particularly interacting with clients or partners that have demanding regulatory needs. It’s valuable to have that quality program in place,” said Markin.

What’s Next for HTD Health?

HTD Health is in the process of obtaining ISO 13485 certification, and having a compliant, modern eQMS on their side has been a huge help. 

The team is also hard at work on a chassis accelerator, bringing together some of the most capabilities that HTD Health has built. The chassis will allow clients to move even more quickly as they build companion applications for their medical devices.