NeuroDerm Ltd.

The conformity of the devices is appropriately checked, in accordance with NeuroDerm’s Quality Management System requirements, before a device is released; The post-market surveillance system (PMS) implemented at NeuroDerm, and keep up to-date, PMS obligations are complied with in accordance with MDR Article 10 (10);

The Technical documentation and the EU Declaration of Conformity are drawn up and kept up to date. The Declaration of Conformity shall be signed prior to release of product; The regulatory reporting obligations (vigilance, field safety corrective action, trend reporting - as defined in MDR Articles 87 to 91) are fulfilled; In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV (MDR) is issued;