In this section we cover all aspects related to the development of medical devices, that are not covered by the other sections (software & IEC 62304, risk management & ISO 14971, usability / human factors engineering & IEC 62366).
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 and informations of products, processes or service, ensure the purpose of it more..
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 together more..
How do you differentiate verification and validation, and how are those terms defined? Even the IEC 60601-1 unclearly uses these terms. Find out here how to safely go through authorisation and audit with a precise verification and validation more..
Medical device manufacturers need to subject their products to a clinical evaluation. This article briefly describes the objectives of the clinical evaluation, the regulations that you must meet to in this standalone software, and where to get the special support more..