Officers and regulatory representatives of Sasmar Pharma Limited
MANCINI John-Michael
Review Quality Management
System is implemented in
accordance with EUMDR and
ISO 13485, and conformity of
the product is appropriately
checked before its release into
the market. Review Technical
File and EU declaration of
conformation is maintained.
Review Post Market
Surveillance is implemented
and periodically updated.
Vigilance reporting is
appropriately followed,
including the systematic
reporting of serious incidents, field safety corrective actions
and trend reporting.
Hidden
PADRON GONZALEZ Alexander Ariel
Review Quality Management
System is implemented in
accordance with EUMDR and
ISO 13485, and conformity of
the product is appropriately
checked before its release into
the market. Review Technical
File and EU declaration of
conformation is maintained.
Review Post Market
Surveillance is implemented
and periodically updated.
Vigilance reporting is
appropriately followed,
including the systematic
reporting of serious incidents, field safety corrective actions
and trend reporting.