The manufacturer shall establish, document and implement a quality management system, as described in Article 10(8), and maintain its effectiveness throughout the life cycle of the devices concerned.
Déanfaidh an monaróir córas bainistithe cáilíochta a bhunú, a dhoiciméadú agus a chur chun feidhme, faoi mar a thuairiscítear in Airteagal 10(8), agus caomhnóidh sé a éifeachtacht feadh shaolré na bhfeistí lena mbaineann.