Sequentia Biotech SL

Responsibilities include: Verify product conformity prior to its release through the quality management system employed in its manufacturing; Ensure that the required technical documentation is complete, updated, and in compliance with applicable regulations; Ensure compliance with post-market surveillance obligations under Article 10, paragraph 9 of the IVDR (In Vitro Diagnostic Medical Devices Regulation); Fulfil notification obligations as referred to in Articles 82 to 86 of the IVDR;