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

Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS requirements for EU MDR 2017/745.  The ISO 13485:2016 specifically requires to

The introduction of the UDI system for the medical device business can be considered a revolution and now the MDR and IVDR will soon be fully implemented, it is necessary