Arrow International Inc.

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 post-market surveillance obligations are complied with in accordance Article 10(10) of The Regulation.

The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; In the case investigational devices, ensuring that the statement referred to in Section 4.1 of Chapter II of Annex XV of The Regulation is issued.

The reporting obligations referred to Article 87 to 91 of The Regulation are fulfilled.