By virtue of the Directorial Decree of December 4, 2025, ECM’s notification scope has been officially updated and now includes the certification of Class III software.

An example of the significance of this new designation is the support for the certification of software for radiographic image analysis for diagnostic purposes in patients with cerebrovascular events.

CONTACT DETAILS

Take advantage of this extension of our Notification Scope and contact us to find out if your Medical Devices fall within our updated Notification Scope.

Contact our Sales Managers:

Diego Stevanella – diego.s@entecerma.it

Marzia Pellegrini – marzia.p@entecerma.it