Dirigeants et représentants réglementaires de Inovyne
BRUCE Alan
1) Conformity to the manufacturers quality system prior to release.
2) Proper Maintenance of the technical documentation and EU declaration of conformity.
3) The post-market surveillance obligations are complied with including post market surveillance plan, post-market report and periodic safety update report as applicable
4) The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting