Dirigeants et représentants réglementaires de ARDG
MONAGHAN Aine
Ensure conformity of the devices is appropriately checked, per QMS devices are manufactured, before release
Ensure post-market surveillance obligations are complied with per Article 10(9).
Ensure reporting obligations referred to in Art 82, Reporting of serious incidents and field safety corrective actions, Art 83 Trend reporting, Art 84 Analysis of serious incidents and field safety corrective actions, Art 85, Analysis of vigilance data, & Art 86 Implementing Acts are adhered to
Masqué
PRIYA Krishna
The technical documentation and the DOC are drawn up and kept up-to-date.
In the case of devices for performance studies, the statement referred to in Section 4.1 of Annex XIV is issued as applicable.
Ensuring reporting obligations in Articles 82, Reporting of serious incidents and field safety corrective actions, Article 83 Trend reporting, Article 84 Analysis of serious incidents & FSCA Article 85, Analysis of vigilance data, & Article 86 Implementing Acts are followed.
Masqué
MCNALLY Karen
The technical documentation and the DOC are drawn up and kept up-to-date.
In the case of devices for performance studies, the statement referred to in Section 4.1 of Annex XIV is issued as applicable.
Ensuring reporting obligations in Articles 82, Reporting of serious incidents and field safety corrective actions, Article 83 Trend reporting, Article 84 Analysis of serious incidents & FSCA Article 85, Analysis of vigilance data, & Article 86 Implementing Acts are followed.