Blue Spark Technologies, Inc.

The conformance of the devices is checked in accordance with the Quality Management System under which the devices are manufactured before the devices are released. The Technical Documentation and the EU Declaration of Conformity are drawn up and kept up to date. The Post Market Surveillance obligations are complied with. The reporting obligations referred to in Articles 87 to 91 are fulfilled. In the case of Investigation Devices, the statement referred to in section 4.1 are met.