Medical Devices

FQS support the implementation of a Quality Management System for manufacture and distribution of Medical devices in compliance with Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) and ISO13485:2016

We offer several services, tailored at your needs:

MDR Transition

QMS and Regulatory Support

QMS Activities Support