Case Study: Elvie launches FDA-compliant wireless breast pump apps with Monterail

Elvie builds FDA-compliant companion apps in 26 months with Monterail

Elvie, a British FemTech company, needed native mobile companion apps for their groundbreaking wireless breast pump to bring the product to market. Their challenge involved developing iOS and Android apps capable of controlling two pumps simultaneously via Bluetooth, syncing complex session data, and meeting strict FDA and EU medical device regulatory compliance. They partnered with the software development vendor Monterail to build this critical software layer from scratch.

Monterail built the iOS and Android applications, implementing a unified BLE abstraction layer to support multiple pump generations and a custom data synchronization service. Their solution included an automated hardware-in-the-loop test rig and a system to auto-generate compliance documentation. The results were two award-winning apps that supported Elvie's growth into a market leader over 11 years of collaboration, successfully navigating regulatory reviews and scaling across three product generations.

Elvie