Dirigeants et représentants réglementaires de Reanzen Co., Ltd.
1 contact identifié
CHOI Sang-bum
The conformity of the devices is appropriately checked, under the QMS under which device is manufactured, before they are released; the technical documentation and the EU DoC are drawn up and kept up-to-date; the post-market surveillance obligations are complies with Regulation Art.10(10); the reporting obligations referred to in the Regulation Art.87-91 are fulfilled; in the case of investigational devices, the statement referred to in Sec.4.1 of Chapter II Annex XV of the Regulation is issued.