Officers and regulatory representatives of Gunter Medical GmbH
PROKOSHEVA Alla
Responsible for regulatory compliance in accordance with Article 15 of Regulation (EU) 2017/745 (MDR), permanently and continuously at the disposal of the SME manufacturer. Ensures conformity of devices before release, maintenance of technical documentation and EU DoC, compliance with post-market surveillance and vigilance reporting (Articles 87–91), and issuance of statements for investigational devices (Annex XV).