Avenda Health Gets SaMD Product to Market Easier with Greenlight Guru’s Purpose-Built QMS

Avenda Health: Artificial Intelligence for Prostate Cancer Mapping & Treatment

Avenda’s artificial intelligence software supplies physicians with a cancer map  with more precision and accuracy than a traditional MRI. This provides physicians with a clearer understanding of the extent of disease  to improve patient outcomes.

The company's mission is to improve the quality of life, treatment planning, and outcomes for men diagnosed with prostate cancer. To get their novel device to market, Avenda needed a powerful and intuitive Quality Management System (QMS) built specifically for MedTech companies.

Challenges

Avenda Health’s team is dispersed across the country. Collaboration across product development and quality teams was difficult without a single source of truth everyone could rely on.

Additionally, navigating the regulatory climate to bring their SaMD product to market was no easy feat. Staying up to date with requirements and documentation, all while ensuring the teams from coast to coast were aligned was a top priority for Avenda.

The Solution: Greenlight Guru

A QMS that also provides Industry Training, Templates, and Academy

Greenlight Guru dramatically improved the way Avenda’s business was collaborating on their medical device development, Womack added Partnering with Greenlight Guru has helped their team beyond providing them with a powerful QMS solution. They’ve found the industry education, SOP templates, courses, training workshops, and Greenlight Guru Academy to be useful. 

“Our partnership with Greenlight Guru gives us great QMS software made for us. But also, we get access to so many comprehensive resources and support that help us as a medical device company.” - Crystal Womack, Quality Manager

The Results: Benefits of Using Greenlight Guru

“Greenlight Guru is very user-friendly and easy to learn across all skill levels. Being able to create links to anything in the software has been a game-changer, ” - Crystal Womack, Quality Manager

Increased Efficiency

Greenlight Guru’s eQMS and audit-ready SOP templates have helped Avenda Health implement their quality system, streamline compliance and get to market faster and more efficiently.

We save so much time because we are able to now collaborate remotely and because Greenlight Guru is just that easy to use. Any skill level can easily get started.”  - Crystal Womack, Quality Manager

Obtained their second 510(k) clearance 

“You provide critical industry training and ‘how to’ content about regulations that save the team hours of searching and trying to understand on our own” - Crystal Womack, Quality Manager

After obtaining FDA clearance, Avenda had the green light to hit the market with their Unfold AI device. They were able to do so with ease because all their documentation, training, and design history was easily accessible in their eQMS. 

What’s Next for Avenda Health?

Avenda Health will leverage Greenlight Guru’s Audit, CAPA, Nonconformance, and Customer Compliant workspaces to manage their SaMD product’s post-market surveillance activities.