II.1)
Scope of the procurement
Medical Device Manufacture for a Research consortium led by Trinity College Dublin
Reference number:
TCD-19-127 Medical Device
33190000
-
Miscellaneous medical devices and products
Supplies
II.1.4)
Short description
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.
II.1.6)
Information about lots
This contract is divided into lots:
no
II.1.7)
Total value of the procurement
Value excluding VAT:
325000.00
EUR
II.2.2)
Additional CPV code(s)
33190000
-
Miscellaneous medical devices and products
II.2.4)
Description of the procurement
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.
Criteria below
Quality criterion
-
Name:
Deliverables (Responsibilities)
/
Weighting:
20%
Quality criterion
-
Name:
Detailed response with regard to Deliverables (Methodology)
/
Weighting:
20%
Cost criterion
-
Name:
Build costs
/
Weighting:
60%
II.2.11)
Information about options
Options:
no
II.2.13)
Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
yes
Identification of the project:
EIT KIC 2020 innovation grant Selio (20186)