Date of dispatch of this notice: 13/12/2019
Expire date: 20/01/2020
External Reference: 2019-284974
TED Reference: 2019/S 243-596608
Contract notice
Information
Published
Contract notice
[NoticeContract]
[Directive201424]
[Section1]: [Ca]
I.1)
[NameAddressContact]
Trinity College Dublin, the University of Dublin
2200007u
College Green
Dublin 2
Co. Dublin
IE
[Contactpoint]:
Kevin Ryan
[AddressPhone]:
+353 18962376
[AddressEmail]:
ryank8@tcd.ie
[Internets]:
[UrlGeneral]:
http://www.tcd.ie
[UrlBuyerprofile]:
https://irl.eu-supply.com/ctm/Company/CompanyInformation/Index/336
I.3)
[InfoTendering]
[DocsRestricted]:
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE[AddressFurtherinfo]
[AsContactsAbove]:
[AddressSendTendersRequest]
[AddressSendTenders]:
http://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=159813&B=ETENDERS_SIMPLE
[AddressSendTendersRequest]
[AddressToAbove]
I.4)
[CaType]
[MaintypePublicbody]
I.5)
[Mainactivity]
[MainactivEducation]
[Section2]: [Object]
II.1)
[QuantityScopeContract]
II.1.1)
[TitleContract]
Medical Device Manufacture for a Research consortium led by Trinity College Dublin
[Fileref]:
TCD-19-127 Medical Device
II.1.2)
[CpvMain]
33190000
-
II.1.3)
[TypeContract]
[Supplies]
II.1.4)
[DescrShort]
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.
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.1.5)
[ValueMagnitudeEstimatedTotal]
[ValueExclVat]: 350000.00
EUR
II.1.6)
[LotsInfo]
[DivisionLots]:
[No]
II.2)
[Description]
II.2.2)
[CpvAdditional]
33190000
-
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.
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.2.5)
[AwardCriteria]
[AwardCriteriaDescriptive]
II.2.6)
[ValueMagnitudeEstimated]
[ValueExclVat]: 350000.00
EUR
II.2.7)
[DurationContractFrameworkDps]
[DurationMonths]:
48
[RenewalsSubject]:
[No]
II.2.9)
[LimitOperators]
[EnvisagedMin]:
1
/
[MaxNumber]:
3
[CriteriaChoosingLimited]:
It is possible only one bidder will respond to this competition due to the specialised requirement.
II.2.10)
[VariantsInfo]
[VariantsAccepted]:
[No]
II.2.11)
[OptionsInfo]
[Options]:
[No]
II.2.13)
[EuProgrInfo]
[EuProgrRelated]:
[Yes]
[EuProgrRef]:
EIT KIC 2020 innovation grant Selio (20186)
[Section3]: [InfoLegal]
III.1)
[ConditionsParticip]
III.1.2)
[EconomicFinancialStanding]
[CriteriaSelectionDocs]
III.1.3)
[TechnicalCapacity]
[CriteriaSelectionDocs]
III.2)
[ConditionsContract]
III.2.3)
[StaffResponsible]
[StaffResponsibleIndicate]
[Section4]: [Procedure]
IV.1)
[Description]
IV.1.1)
[TypeProcedure]
[ProctypeRestricted]
IV.1.3)
[FrameworkContractDpsInfo]
[NoticeInvolvesFramework]
[FrameworkSingle]
IV.1.8)
[GpaInfo]
[GpaCovered]
: [Yes]
IV.2)
[InfoAdmin]
IV.2.2)
[LimitReceiptTendersReqPart]
[Date]:
20/01/2020
[Time]:
12:00
IV.2.3)
[DateDispatchTenderParticipate]
[Date]: 24/02/2020
IV.2.4)
[LanguagesAllowed]
[Language_EN]
IV.2.6)
[MinTimeMaintain]
[DurationMonths]
: 48
([FromStatedDate])
[Section6]: [InfoComplement]
VI.1)
[RecurrenceInfo]
[RecurrentProcurement]:
[No]
VI.2)
[InfoEworkflow]
[EorderingUsed]
[EinvoicingUsed]
[EpaymentUsed]
VI.4)
[AppealsProcedure]
VI.4.1)
[AppealsBody]
High Court
Dublin
IE