Officers and regulatory representatives of RIATLAS
ROMANELLI LUCA
the management actions of the quality and product system and the applicable responsibilities provided by Article 15 of Regulation 2017/745. For the quality system the PRRC ensures and foresees:
the development, implementation and maintenance of the quality management system in accordance with EN ISO 13485 and UNI EN ISO 27001. For medical devices the PRRC ensures that: the conformity of the devices is adequately checked in accordance with the quality management system, etc..