SafeHeal SAS

(a) the conformity of the devices is appropriatelychecked, before a device is released; (b) the technicaldocumentation and the EU declaration of conformity aredrawn up and kept up-to-date; (c) the post-marketsurveillance obligations are complied with in accordancewith Article 10(10); (d) the reporting obligations referredto in Articles 87 to 91 are fulfilled; (e) in the case ofinvestigational devices, the statement referred to inSection 4.1 of Chapter II of Annex XV is issued.