30/10/2025

Gabi SmartCare

 

CASE STUDY

 

FROM INITIAL STRATEGY TO FDA CLEARANCE FOR A PIONEERING HOME MONITORING DEVICE

 

 

Background

Gabi SmartCare was founded in 2017 by two Belgian entrepreneurs with the vision of creating a next-gen babyphone: a connected bracelet capable of monitoring a child’s sleep and vital signs at home. The founders recognized that bringing medical-grade monitoring into the home in a simple, parent-friendly format would help the pediatric patients to go back home sooner and would decrease the delay of care post hospitalization. The founders aimed to make health monitoring more comfortable for children, more practical for families, and more scalable for healthcare providers.

 

What We Did

At the time Gabi was conceiving its device, the digital health sector was rapidly expanding, and so were the regulatory requirements surrounding it. Since the device provided more than simple tracking data, it was classified in Europe as a Class IIa medical device, with a burdensome regulatory process for a time-pressed start-up. Gabi partnered with COVARTIM to first determine the regulatory strategy. We opted for FDA clearance first through a 510(k), due to the transparency and predictability of the process, and the market size. We then began managing regulatory and quality assurance process. We implemented our APEX® Quality Management System, compiled their complete technical documentation, and supported the US submission. As part of the process we supported end-to-end a summative usability study on 17 parent/child couples and 20 physicians.

Outcome

The project resulted in a smooth regulatory pathway and robust quality system implementation. Gabi SmartCare achieved ISO 13485 certification in 2022 with no non-conformities, followed by FDA clearance in 2023. The company’s regulatory success marked the start of a market adoption period, and a new commercial strategy which ultimately led to its acquisition by Hinlab.

 

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