Class III medical devices

Class III medical devices are the most regulated type, used for life-support, sustaining, or critical health functions. They often include devices like implantable pacemakers, heart valves, and brain stimulators. These devices pose higher risks if they malfunction, so they require rigorous testing, clinical trials, and approval from regulatory agencies like the FDA before they can be marketed. Their design, manufacturing, and performance are closely monitored to ensure safety and effectiveness for patients relying on them for vital health needs.