Intersurgical Ltd

Conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (as per requirement Article 10(9) of the Regulation (EU) 2017/745). EU declaration of conformity (Article 10(6), as per Article 19 of the Regulation (EU) 2017/745) are drawn up and kept up-to-date.

Technical documentation (as per Article 10(4), as per Annexes II and III of the Regulation (EU) 2017/745) drawn up and kept up-to-date. In the case of investigational devices, the statement (as per Section 4.1 of Chapter II of Annex XV of the Regulation (EU) 2017/745) is issued.

Post-market surveillance obligations are complied with in accordance with Article 10(10) (as per Article 83 of the Regulation (EU) 2017/745).

Reporting obligations, Vigilance obligations (as per Articles 87 to 91 of the Regulation (EU) 2017/745) are fulfilled; namely: - Reporting of serious incidents and field safety corrective actions, - Trend reporting, - Analysis of serious incidents and field safety corrective actions, - Analysis of vigilance data.

Reporting obligations, Vigilance obligations (as per Articles 87 to 91 of the Regulation (EU) 2017/745) are fulfilled; namely: - Reporting of serious incidents and field safety corrective actions, - Trend reporting, - Analysis of serious incidents and field safety corrective actions, - Analysis of vigilance data.