Biocompatibility evaluation according to ISO 10993-1 is one of the most important validation activities for…
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview…
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical…
ISO 15223-1:2020 new symbols for medical devices In this paragraph, we will talk about the…
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO…
Within 2020, a new standard is expected to be published: it is named ISO 20417…
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes…