LifeScan U.S. LLC

Article 15. 3(a) The 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

Article 15 3(b). The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 3(e). In the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV (for IVDR) and of Annex XV (for MDR) is issued.

Article 15.3(a) The 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. (Digital Representative) Article 15.3(c) The post-market surveillance obligations are complied with in accordance with Article 10(9) (for IVDR) and Article 10(10) (for MDR). Article 15.3(d) The reporting obligations referred to in Articles 82 to 86 (for IVDR) and Articles 87 and 91 (for MDR) are fulfilled.

Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding regulatory requirements for medical devices in the Union.

Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding regulatory requirements for medical devices in the Union.