• Conformity of the devices is appropriately checked, in accordance with the quality management system under
• Technical documentation and the EU declaration of conformity are drawn up and kept up to date.
• Post-market surveillance obligations
The statement referred to in EU MDR Section 4.1 and / or the statement referred to in EU IVDR Section 4.1
• Reporting obligations referred to in Articles 87 to 91 for EU MDR or Articles 82 to 86 for EU IVDR, are fulfilled.