TTK Healthcare Limited Heart Valve Division

To ensure product’s compliance to QMS as per the requirements of MDR 2017/745 and EN ISO 13485:2016 To verify the conformity of the devices with the quality management system, before a device is released.

To ensure that the post-market surveillance obligations are complied with in accordance with Article 10(10); To fulfil the reporting obligations as in Articles 87 to 91 of 2017/745. To meet the obligations of investigational devices referred to in Section 4.1 of Chapter II of Annex XV. Perform analysis and reporting of serious incidents, field safety corrective actions, EU Trend and vigilance data. To identify revised/ new regulatory requirements and ensure compliance and action plan.

To compile the technical documentation as per 2017/745and periodically review to ensure that it is up-to-date. To draw the EU declaration of conformity and keep it up-to-date Analysis of complaint/returned device To ensure product’s compliance to QMS requirements as in Article 10 of 2017/745. Responsible in handling communication with the notified body.