Working groups
Working groups
Develop an aligned approach to the management of artificial intelligence based medical devices.
Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.
Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
Develop good review practices for pre-market reviews and evaluations.
Harmonize the format and content of regulatory submissions.