Skip to content

eHealth Sussie - Guide for app developers, manufacturers and distributors

The Guide for app developers, manufacturers and distributors issued by eHealth Suisse focuses on software (in the form of an app) as a medical device. The guideline provides the regulatory framework in Switzerland and explains how to address cybersecurity.

The document states that security needs to be addressed from the design stage providing a list of typical points, then through a risk management process also giving examples and referring to international standards that are mandatory, and finally refers to verification and validation.

This guide also emphasizes that manufacturers have obligations after the software has been developed, such as secure updates, response to security risks and product surveillance system.

The guideline is publicly available here: eHealth Sussie - Guide

Issuer: Swiss Competence and Coordination Centre of the Confederation and the Cantons

Tags: guideline • software • switzerland