Medical Device Manufacture for a Research consortium led by Trinity College Dublin

Trinity College Dublin, the University of Dublin

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:

• Arrotek Medical

Who?

• Trinity College Dublin, the University of Dublin

What?

• Medical equipments › Miscellaneous medical devices and products

Where?

• Eastern and Midland › Dublin

Procurement history

Date	Document
2019-12-13	Contract notice
2020-09-30	Contract award notice

Contract notice (2019-12-13)
Object
Scope of the procurement
Title: Miscellaneous medical devices and products
Reference number: TCD-19-127 Medical Device
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.

Notice metadata
Original language: English 🗣️
Document type: Contract notice
Nature of contract: Supplies
Regulation: European Union, with participation of GPA countries
Common procurement vocabulary (CPV)
Code: Miscellaneous medical devices and products 📦
Additional CPV: Miscellaneous medical devices and products 📦
Place of performance
NUTS region: Dublin 🏙️

Procedure
Procedure type: Restricted procedure
Type of bid: Submission for all lots
Award criteria
The most economic tender

Contracting authority
Identity
Country: Ireland 🇮🇪
Awarding authority type: Body governed by public law
Awarding authority name: Trinity College Dublin, the University of Dublin
Postal address: College Green, Co. Dublin
Postal town: Dublin 2
Contact
Internet address: http://www.tcd.ie 🌏
E-mail: ryank8@tcd.ie 📧
Phone: +353 18962376 📞
URL for documents: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE 🌏
URL for participation: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE 🌏

Reference
Dates
Date dispatched: 2019-12-13 📅
Submission deadline: 2020-01-20 📅
Publication date: 2019-12-17 📅
Identifiers
Notice number: 2019/S 243-596608
OJ-S issue: 243

Object
Scope of the procurement
Short description:

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.

Estimated total value: 350 000 EUR 💰
Estimated value excluding VAT: 350 000 EUR 💰
Duration: 48 months
Name of EU-financed project or programme: EIT KIC 2020 innovation grant Selio (20186)

Procedure
Legal basis: 32014L0024
Minimum number of candidates: 1
Maximum number of candidates: 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.

Time of receipt of tenders: 12:00
Date of dispatch of invitations: 2020-02-24 📅
Languages in which tenders or requests to participate may be submitted: English 🗣️
Tender validity period: 48 months

Contracting authority
Identity
National registration number: 2200007u
Contact
Contact point: Kevin Ryan
Address of the buyer profile: https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/336 🌏
Documents URL: http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE 🌏

Complementary information
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 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.

Total value of the procurement: 325 000 EUR 💰
Notice metadata
Document type: Contract award notice

Procedure
Type of bid: Not applicable

Reference
Dates
Date dispatched: 2020-09-30 📅
Publication date: 2020-10-05 📅
Identifiers
Notice number: 2020/S 193-466112
Refers to notice: 2019/S 243-596608
OJ-S issue: 193

Object
Scope of the procurement
Short description:

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.

Name of EU-financed project or programme: EIT KIC 2020 innovation grant Selio (20186).

Procedure
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 %

Award of contract
Date of contract conclusion: 2020-09-08 📅
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 📧
Country: West 🏙️
Total value of the procurement: 325 000 EUR 💰
Information about tenders
Number of tenders received: 1
Source: OJS 2020/S 193-466112 (2020-09-30)

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