Case Study: Fractyl Health achieves faster medical device compliance with Perforce ALM

How to Achieve Medical Device Compliance Fast Fractyl’s Story

Fractyl Health, a medical technology company developing the Revita™ duodenal mucosal resurfacing (DMR) system, needed to speed up a time-consuming, manual compliance process without sacrificing product quality or patient safety. Its team had been managing requirements in Microsoft Word and issues in Jira, but lacked an efficient way to create the traceability needed for FDA and ISO compliance. Perforce ALM was the vendor solution they chose to help address this challenge.

With Perforce ALM, Fractyl Health automated traceability across requirements, issues, test cases, and test runs, making it easier to build compliant traceability matrices and maintain approval controls during testing. As a result, Perforce helped Fractyl achieve ISO 13485 certification and a CE Mark 12 months ahead of schedule, improving compliance speed while supporting safer, thoroughly tested product development.

Fractyl Health

Ann Rossi

Senior Software Quality Assurance Manager