Case Study: EvoEndo streamlines quality management and FDA compliance with Qualio

We asked EvoEndo's CEO how Qualio has impacted her business

EvoEndo, a Centennial, CO-based medical device company developing a single-use gastroscope system, needed a better way to manage quality as it prepared for FDA 510(k) clearance. Its previous on-premise eQMS was clunky, paper-heavy, and hard for a remote team to use, making document control, review, and training management inefficient. Qualio was chosen as the cloud-based eQMS to help replace that outdated setup.

With Qualio, EvoEndo implemented a streamlined, intuitive cloud QMS covering document control, training, quality events, design controls, and more, supported by templates and hands-on customer success help. The results were “night and day”: document review and signatures became much faster, adoption jumped because everyone used the system, and Heather Underwood could manage quality on the go. Qualio helped EvoEndo grow through Series A funding and contributed to the company’s FDA 510(k) clearance in February 2022.

EvoEndo

Heather Underwood

Chief Executive Officer