GreenBone Ortho Spa

1) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 2) the post-market surveillance obligations (PMS Plan, PSUR) are complied with in accordance with Article 10(10) 3) to ensure the vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled

The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; 

1) the technical documentation (CEP, CER, SSCP) is drawn up and kept up-to-date; 2) the post-market surveillance obligations (PMCF) are complied with in accordance with Article 10(10) 3) to ensure  in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.