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

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

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

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

The Declaration of Conformity is one of the key document asked to be prepared by medical device manufacturer in order to declare the compliance of their products and related quality