Case Study: Avenda Health achieves faster 510(k) clearance with Greenlight Guru's QMS

How Greenlight Guru helped Avenda Health obtain their second 510(k) clearance faster so they could get to market and start improving outcomes for cancer patients

Avenda Health, a software-as-a-medical-device company focused on AI for prostate cancer mapping and treatment, needed a better way to collaborate across a dispersed team while staying current on regulatory requirements and documentation. Working with Greenlight Guru, they used a purpose-built QMS along with Academy resources, SOP templates, and industry training to support their medical device development.

Greenlight Guru helped Avenda Health streamline quality management, improve remote collaboration, and accelerate compliance so the team could bring its SaMD product to market faster. As a result, Avenda Health obtained its second 510(k) clearance more quickly and was able to launch its Unfold AI device with documentation, training, and design history easily accessible in the eQMS.

Avenda Health

Crystal Womack

Quality Manager