Regulatory requirements for Active Medical Devices

A critical success factor for developing an active medical device (those with electronics hardware and software) is having a clear regulatory strategy. Having a clear pathway from concept, through clinical trials to regulatory acceptance in target markets guides the roadmap technological development. 

This 40-minute presentation will explore the compliance and certification requirements for creating and marketing active medical devices. The role of notification bodies such as the TGA, FDA, CE will be outlined along with the main regulatory standards, particularly those relating to active medical devices. 

The key activity of classifying your device is explained. We then set out the pathway to certification, including the role of predicate devices, verification and validation, clinical trials and the certification process.