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

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

ISO 13485 FDA ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we want to discuss about the future integration between ISO