OrthAlign, Inc

1. Ensuring that: a. The conformity of the device(s) are appropriately checked, per the QMS which the devices are manufactured, prior to release b) The technical documentation and the EU D of C are drawn up and kept up-to-date; c. post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR. d. The reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.