PDG Product Design Group Inc.

Check the conformity of PDG’s devices in accordance with the QMS under which the devices are manufactured, before a device is released; Draw up and keep up-to-date the technical documentation and the EU declaration of conformity; Compile the post-market surveillance obligations in accordance with Article 10(10); Fulfill the reporting obligations referred to in Articles 87-91; In the case of investigational devices, Issue the statement referred to in Section 4.1 of Chapter II of Annex XV.