II.1)
[QuantityScopeContract]
Medical Device Manufacture for a Research consortium led by Trinity College Dublin
[Fileref]:
TCD-19-127 Medical Device
[Supplies]
Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated with percutaneous access of the body. The device is designed for use as part of a CT-guided interventional procedure with the end-user being an Interventional Radiologist.
Trinity College Dublin is seeking a suitable Contract Manufacturing Organisation (CMO) that can facilitate the development, manufacture, assembly, packaging & sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their Quality Management System. All design & quality files generated as part of this development process must be suitable to be included in the Design History File for the product.
[DivisionLots]:
[No]
[ValueExclVat]:
325000.00
EUR
II.2.4)
[DescrProcurement]
Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated with percutaneous access of the body. The device is designed for use as part of a CT-guided interventional procedure with the end-user being an Interventional Radiologist.
Trinity College Dublin is seeking a suitable Contract Manufacturing Organisation (CMO) that can facilitate the development, manufacture, assembly, packaging & sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their Quality Management System. All design & quality files generated as part of this development process must be suitable to be included in the Design History File for the product.
[AwardCriteriaBelow]
[AwardCriterionQuality]
-
[AwardCriterionName]:
Deliverables (Responsibilities)
/
[Weighting]:
20%
[AwardCriterionQuality]
-
[AwardCriterionName]:
Detailed response with regard to Deliverables (Methodology)
/
[Weighting]:
20%
[AwardLowestCost]
-
[AwardCriterionName]:
Build costs
/
[Weighting]:
60%
[Options]:
[No]
[EuProgrRelated]:
[Yes]
[EuProgrRef]:
EIT KIC 2020 innovation grant Selio (20186)