Officers and regulatory representatives of Innovation Zed
BOUGHTON Carolyn
- 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
- Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
- Post-market surveillance obligations are complied with in accordance with Article 10(10);
- The reporting obligations referred to in Articles 87 to 91 are fulfilled;