Next Science LLC

In the case of investigational devices, there is a signed statement that the device in question conforms 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.

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. The technical documentation and EU declaration of conformity are drawn up and kept up to date. The post market surveillance obligations are complied with in accordance with EU MDR. The reporting obligations are fulfilled.