Vivid Vision Inc

Company's regulatory affairs in specific activities including: FDA submissions, EU compliance, technical documentation

(a)Ensuring conformity of devices is appropriately checked, in accordance with the quality management system, before a device is released; (b)technical documentation and the EU DoC are drawn up and up to date; (c)post-market surveillance obligations are complied with Article 83 MDR; (d)reporting obligations referred to in Articles 87 to 91 MDR are fulfilled, e.g. serious incident reporting;(e)in the case of investigational devices, statement referred to in Sec 4.1 of Ch II of Annex XV is issued.