Officers and regulatory representatives of Sochim International s.r.l.
EIGENMANN Carolina
a) conformity of the devices, in accordance with the quality management system under which the devices are manufactured, before a device is released;” B) maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this MDR Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device ”the post-market surveillance obligations are complied with in accordance with MDR