Coroneo Inc.

Regulatory compliance according to R2017/745, Article 15, ensures the conformity of the devices is checked before release, the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date, the post-market surveillance obligations are complied with according to Article 10(10), the reporting obligations in Articles 87 to 91 are fulfilled, in the case of investigational devices, the statement in Section 4.1 of Chapter II of Annex XV is issued.