FDA Medical Device Class III
Class III Devices
Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.
Examples of Class III devices include implantable pacemakers and breast implants.
Here at FDACE PRO, our executive management has almost 12 years of combined experience in delivering compliance software and services in regulated industries. We are dedicated to providing the knowledge, skills, and resources to suit your individual requirements for all Enterprise Compliance Software projects.
Contact us today to find out how we can help you with your Unique Device Identification challenges.