Working groups

Working groups

medical-device-cybersecurity-guide

Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.
personalized-medical-device

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.
adverse-event-terminology

Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.