Officers and regulatory representatives of SIMON Sp. z o.o.
CZYBIS Witold
ensuring that: -conformity of devices is checked, in accordance with quality management system, before a device is released -technical documentation and EU declaration of conformity are drawn up and kept up-to-date -post-market surveillance obligations are complied with in accordance with Article 10(10) -reporting obligations from Art. 87 to 9 are fulfilled - in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.