Medical Apps

Mobile Medical Apps Medical Apps also referred to as Mobile Medical Apps, are applications for mobile devices such as smartphones or tablets that support medical professionals or patients in the diagnosis, treatment, or monitoring of a disease or injury. This article...

SOUP and OTS

SOUP – Software of Unknown Provenance SOUP is an acronym for “Software of Unknown Provenance”. The IEC 62304 defines a SOUP as follows: Definition: SOUP „SOFTWARE ITEM that is already developed and generally available and that has not been developed for...

Safety Classes & Level of Concern

Software Safety Classes (IEC 62304) versus Levels of Concern (FDA) Both, European and US regulations, distinguish three different categories of medical device software, the software safety classes accordingly to IEC 62304 respectively the FDA levels of concern....

Software Lifecycle

Software Life Cycle Processes for Medical Devices 1. Overview on software life cycle processes The software life cycle covers all activities from the first product idea to deinstallation, respectively decommissioning of the last instance of the product. The software...

Software as Medical Device

Software as Medical Device: Definitions and Classification Aids With software as medical device, it differentiates between standalone software and software that is part of a medical device.  Classifying the standalone (also called SaMD – Software as Medical...