Insight Lifetech Co., Ltd.

1. Ensure compliance with post-market surveillance obligations as stipulated in Article 10(10), and ensure the continuous maintenance of the post-market surveillance system. 2. Ensure fulfillment of reporting obligations as specified in Articles 87 to 91. 3. Ensure the compilation of necessary reports arising from post-market surveillance obligations. 4. Represent the Insight Lifetech PRRC team and report periodically to the management.

Ensure confirmation of product regulatory compliance prior to product release, in accordance with the quality management system governing production.

1.Ensure the development and ongoing updating of product technical documentation and the EU Declaration of Conformity. 2.In the event of an alert, liaise and communicate with the designated unit of the competent authority representative.

For investigational devices, ensure theof the statement referred to in Section 4.1 of Annex XV.