The request
The introduction of the EU Regulation on Medical Devices (MDR) 2017/745 and on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 has determined the need for medical device manufacturers to adapt their technical documentation to the proposed standards in order to market their products.
The solution
In a field that is constantly evolving, FAR.Medical Solutions has supported dozens of medical device manufacturing companies in obtaining the CE marking of their products in compliance with the EU Medical Devices Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746, as well as in the implementation of Quality Management Systems and ISO 13485 certification.