Officers and regulatory representatives of NOVT EUR
BAUERNSACHS Timo
(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) For investigational devices, ensure a signed statement is issued as required under Annex XV Chapter II
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OEHLER Simone
(1) The technical documentation and the EU declaration of conformity for devices sold into the EU market are drawn up and kept up to date.
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JANKE Doreen
(1) The post-market surveillance (“PMS”) obligations are complied with in accordance with Article 10(10) of the EU MDR. (2) The vigilance reporting obligations in Articles 87 to 91 of the EU MDR are fulfilled.