Officers and regulatory representatives of Balton Sp. z o.o.
MICKIEWICZ Adam
The person responsible for regulatory compliance with:
(a) 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;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.
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SOJKA Elżbieta
The person responsible for regulatory compliance with:
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);