Designated Person Responsible for Regulatory Compliance (PRRC) according to MDR Article 15. Responsible for ensuring that the conformity of the devices is appropriately checked in accordance with the quality management system before a device is released, that the technical documentation and the EU declaration of conformity are drawn up and kept up to date, and that the post-market surveillance, vigilance and reporting obligations are fulfilled.
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RUI Orinta
Responsible for the establishment, maintenance and oversight of the Quality Management System in compliance with ISO 13485 and MDR requirements, ensuring effective implementation throughout the organisation. Acts as regulatory contact for communication with Competent Authorities.