Case Studies

The client, a prominent Digital Health startup headquartered in Canada, specializes in an A.I.-powered medical platform designed for accurate, real-time remote patient monitoring. Ensuring compliance with U.S. FDA standards posed a challenge for the client in ensuring the availability of all device data. To address this issue, the client sought the expertise of 8C Healthcare to conduct a thorough assessment of the 510(k) Technical File gaps. 

Explore the details of how 8C Healthcare assisted the client in securing the 510(k) clearance for their device in this documented success story.