System Architecture

System Architecture for Medical Devices The System Architecture describes how a (medical) product is composed of components and how the components are related to each other via interfaces. In stand-alone software systems, architecture and software architecture fall...

Intended Use Description

Intended Use and the Usage According to Regulations Intended Use (check out also GHTF/SG1/N70:2011) is an objective aim of medical products manufacturers related to the purpose of the products, processes, or service. It is about how the specification, instructions,...

Amendment to IEC 60601-1

2. Amendment to IEC 60601-1 – What has A2:2019 changed compared to A1:2012? As planned, there is a first Committee Draft for Vote (CDV) for Amendment 2 to IEC 60601-1. This is also referred to as IEC 60601-1 A2:2019. We have summarised the most important points from...