ISO 18113 : Labelling Requirements for IVD Medical Devices
ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in…
Electronic IFU (eIFU) for Medical Devices: Key Requirements
eIFU (electronic IFU) became more and more important in the last tears, due to the huge progress of digital health…
UDI Requirements for EU MDR and IVDR
The introduction of the UDI system for the medical device business can be considered a revolution and now the MDR…
ISO 17664: Processing Instructions for Medical Devices
In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been…
FDA Labelling Requirements: An Overview
FDA labelling Requirements
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
ISO 20417 : New ISO Standard on Information to be Provided by Manufacturer
A new standard is expected to be published in early 2021: it is named ISO 20417 Medical devices — Information…