Sasmar Pharma Limited

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.

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.