Officers and regulatory representatives of Healthup S.A.
MIKLASZ Karolina
- the conformity of the devices is appropriately checked, in accordance with Healthup QMS,
- the technical documentation and the EU Declaration of Conformity are drawn up and kept up to date according to Healthup QMS,
- the post-market surveillance obligations are complied with legal requirements and Healthup QMS,
- the reporting obligations related to serious incidents and field safety corrective actions, including trend reporting, are performed according to legal requirements and Healthup QMS.