DIGIMED Co., Ltd.

1.Checking the conformity of the devices before released in accordance with the QMS under which the devices are manufactured 2.Drawing up the technical documents and the EU declaration of conformity and keeping updates. 3.Making sure the post-market surveillance obligations are complied with in accordance with MDR Article 10(10) 4.Fulling the reporting obligations referred to in MDR Articles 87 to 91 5.Issuing the statement referred to in MDR Chapter II of Annex XV for investigational device

1.Checking the conformity of the devices before released in accordance with the QMS under which the devices are manufactured 2.Drawing up the technical documents and the EU declaration of conformity and keeping updates. 3.Making sure the post-market surveillance obligations are complied with in accordance with MDR Article 10(10) 4.Fulling the reporting obligations referred to in MDR Articles 87 to 91 5.Issuing the statement referred to in MDR Chapter II of Annex XV for investigational device