TAISSIS CONCEPT S.R.L.

- Checking the conformity of the devices in accordance with the quality management system (QMS) before release the product on the market, - Preparing and maintaining the technical documentation and EU Declaration of Conformity - Meeting post market surveillance obligations; - Vigilance reporting and analysis requirements are met, including serious incidents, field safety corrective actions and report trending; and - For investigational devices a signed statement that the device meets the GSPRs.

- Checking the conformity of the devices in accordance with the quality management system (QMS) before release the product on the market, - Preparing and maintaining the technical documentation and EU Declaration of Conformity - Meeting post market surveillance obligations; - Vigilance reporting and analysis requirements are met, including serious incidents, field safety corrective actions and report trending; and - For investigational devices a signed statement that the device meets the GSPRs.