Although there are different ISO standards which define the requirements for labelling related to medical device, such us ISO 15223-1 and ISO 20417, FDA has also some specific requirements that

ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to usability. Usability studies are an essential part of the design

Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities for medical device. It is an important process during the

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