GE Medical Systems, LLC

EU MDR Article 15: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up to date; (e) investigational devices conform to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.

Site Top Quality Management Representative and EU MDR Article 15 (a) 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; (c) the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); (d) the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled