KAMIYA BIOMEDICAL COMPANY, LLC

Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS before a device is released, drawing up technical documentation and the EU declaration of conformity and keeping them up-to-date, complying with post-market surveillance obligations, reporting serious incidents and field safety corrective actions to relevant competent authorities, and all other requirements in Article 15 of the EU IVDR.

Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS before a device is released, drawing up technical documentation and the EU declaration of conformity and keeping them up-to-date, complying with post-market surveillance obligations, reporting serious incidents and field safety corrective actions to relevant competent authorities, and all other requirements in Article 15 of the EU IVDR.