IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It

Biocompatibility evaluation according to ISO 10993-1 is one of the most important validation activities for medical device. It is an important process during the design of the device that has

Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation of the design history file (DHF) for medical devices according to

Very recently, ISO published a new version of ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. The new ISO 14155:2020 provides an

ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that will introduce new symbols to add in the labelling of medical