New guide for manufacturers of standalone software

The European Commission has adopted a guide for manufacturers of standalone software that describes the criteria for whether a product is considered a medical device and thus should be CE-marked. In this article, the MPA provides an introduction to the guide. In addition, work has now begun to update the 2009 Swedish guide on Medical Information Systems.

Source: MPA RSS news - - June 12, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news