Mediwhale Inc.

1. 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 2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date

1. 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 2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date 3. the post-market surveillance obligations are complied with in accordance with Article 10(10) 4. the reporting obligations referred to in Articles 87 to 91 are fulfilled

1. the post-market surveillance obligations are complied with in accordance with Article 10(10) 2. the reporting obligations referred to in Articles 87 to 91 are fulfilled