Enterprise Europe Network
HomeParticipantsMarketplace

ServiceUpdated on 30 October 2025

Medical Software Diagnosis

CEO at EFF'INNOV Technologies

Colombelles, France

About

The standard EN 62304 establishes requirements for the lifecycle of medical software.

It covers specification, design, validation, and maintenance, with a focus on risk management.

As a harmonized standard, it enables the demonstration of egulatory compliance for medical software within the EU.

Thorough technical documentation helps secure the acquisition of the CE marking.

Similar opportunities