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 and sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their quality management system. All design and quality files generated as part of this development process must be suitable to be included in the design history file for the product.
Deadline
The time limit for receipt of tenders was 2020-01-20.
The procurement was published on 2019-12-13.
Suppliers
The following suppliers are mentioned in award decisions or other procurement documents:
Object Scope of the procurement
Title:
“Medical Device Manufacture for a Research consortium led by Trinity College Dublin
TCD-19-127 Medical Device”
Products/services: Miscellaneous medical devices and products📦
Short description:
“Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated...”
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 and sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their quality management system. All design and quality files generated as part of this development process must be suitable to be included in the design history file for the product.
Show more
Estimated value excluding VAT: EUR 350 000 💰
1️⃣
Additional products/services: Miscellaneous medical devices and products📦
Place of performance: Dublin🏙️
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...”
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 and sterilization of these sub-components of the Selio Sealant System™. The CMO will develop the product under their quality management system. All design and quality files generated as part of this development process must be suitable to be included in the design history file for the product.
Show more Award criteria
Price is not the only award criterion and all criteria are stated only in the procurement documents
Scope of the procurement
Estimated total value excluding VAT: EUR 350 000 💰
Duration of the contract, framework agreement or dynamic purchasing system
The time frame below is expressed in number of months.
Description
Duration: 48
Information about the limits on the number of candidates to be invited
Envisaged minimum number: 1
Maximum number: 3
Objective criteria for choosing the limited number of candidates:
“It is possible only 1 bidder will respond to this competition due to the specialised requirement.” Scope of the procurement
Information about European Union funds: EIT KIC 2020 innovation grant Selio (20186)
Legal, economic, financial and technical information Economic and financial standing
Selection criteria as stated in the procurement documents
Technical and professional ability
Selection criteria as stated in the procurement documents
Information about staff responsible for the performance of the contract
Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract
Procedure Type of procedure
Restricted procedure
Information about a framework agreement or a dynamic purchasing system
Framework agreement with a single operator
Administrative information
Time limit for receipt of tenders or requests to participate: 2020-01-20
12:00 📅
Estimated date of dispatch of invitations to tender or to participate to selected candidates: 2020-02-24 📅
Languages in which tenders or requests to participate may be submitted: English 🗣️
The time frame below is expressed in number of months.
Minimum time frame during which the tenderer must maintain the tender: 48
Complementary information Information about electronic workflows
Electronic ordering will be used
Electronic invoicing will be accepted
Electronic payment will be used
Review body
Name: High Court
Postal town: Dublin
Country: Ireland 🇮🇪
Source: OJS 2019/S 243-596608 (2019-12-13)
Contract award notice (2020-09-30) Object Scope of the procurement
Short description:
“Researchers within Trinity College Dublin have developed the Selio Sealant System™, a sterile, single-use medical device to prevent complications associated...”
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 and sterilisation of these sub-components of the Selio Sealant System™. The CMO will develop the product under their quality management system. All design and quality files generated as part of this development process must be suitable to be included in the design history file for the product.
Show more
Total value of the procurement (excluding VAT): EUR 325 000 💰
Description
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...”
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 and sterilisation of these sub-components of the Selio Sealant System™. The CMO will develop the product under their quality management system. All design and quality files generated as part of this development process must be suitable to be included in the design history file for the product.
Show more Award criteria
Quality criterion (name): Deliverables (responsibilities)
Quality criterion (weighting): 20 %
Quality criterion (name): Detailed response with regard to deliverables (methodology)
Cost criterion (name): Build costs
Cost criterion (weighting): 60 %
Scope of the procurement
Information about European Union funds: EIT KIC 2020 innovation grant Selio (20186).
Procedure Information about framework agreement
The procurement involves the establishment of a framework agreement
Administrative information
Previous publication concerning this procedure: 2019/S 243-596608
Award of contract
1️⃣
Contract Number: 1
Title:
“Medical Device Manufacture for a Research consortium led by Trinity College Dublin”
Date of conclusion of the contract: 2020-09-08 📅
Information about tenders
Number of tenders received: 1
Number of tenders received from SMEs: 1
Name and address of the contractor
Name: Arrotek Medical
Postal address: Finisklin Business Park
Postal town: Sligo
Postal code: F91 RR99
Country: Ireland 🇮🇪
Phone: +353 719115111📞
E-mail: ronan@arrotek.com📧
Region: West🏙️
The contractor is an SME ✅ Information on value of the contract/lot (excluding VAT)
Estimated total value of the contract/lot: EUR 325 000 💰
Total value of the contract/lot: EUR 325 000 💰
Source: OJS 2020/S 193-466112 (2020-09-30)