Officers and regulatory representatives of DAVID MEDICAL EUROPE, UNIPESSOAL LDA
TELES LILIANA
1. 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;
2. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
3. Compliance with post-market surveillance obligations and incident reporting obligations
4. in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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