Hemocompatibility of Medical Devices: an Overview
Hemocompatibility is on of the test requested to assess the safety of a medical devices that come in contact with blood. It is obvious that among the whole set of
Free Sale Certificate according to EU MDR
The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating the export of medical device and in-vitro diagnostic devices outside
Product Life Cycle for Medical Devices
The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and adequate development of the medical product under development. The definition of
Harmonised Standards and EU MDR 2017/745
The definition of harmonised standards (HS) is reported in a specific section of EU Medical Device Regulation 2017/745 and precisely in the Article 2 of the regulation. Specifically, harmonised standard
Substantial Changes for Design and Quality System: an Overview
The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about Design Changes and the management of change control and we
