Dirigeants et représentants réglementaires de POLLUX
STODŮLKA Pavel
- to maintain the compliance of IVDs with applicable regulations requirements and QMS
- to release the products after final control
- to prepare and regularly update the technical documentation and EU Declaration of conformity
- to ensure compliance with the post-market surveillance (PMS) obligations
- to prepare and regularly update PSUR
- to fulfil the reporting obligations relating to reporting of serious adverse events, field safety corrective actions (FSCA) and reporting trends