Framework Agreement for Medical - Framework Agreement for the Medical Device manufacture, assembly, packaging

Cork Institute of Technology

CIT requires a suitably qualified medical device manufacturer which the capability and capacity to manufacture product to the Institute's specific requirements and to work with it to achieve CE marking and FDA approval for this medical device.
The intention will be to place Applicants that demonstrate their capability and capacity to meet CIT's needs on a Framework Agreement. During the life of that Agreement, when CIT has a developed product which it believes is ready for volume manufacture and regulatory submission, CIT will invite all those Applicants admitted to the Framework Agreement to submit tender for that opportunity.
It is anticipated that Applicants admitted to the Framework Agreement will meet the following requirements:
— A Medical Device manufacture with a validated clean-room facility to class 10,000,
— Have an accredited Quality Management System to ISO 13485 for Medical Device Manufacture,
— An accredited Quality Management System to cover Design Control would be advantageous,
— Experience in working with Institute of Technology on Enterprise Ireland Commercialisation Funds or experience with Start-Up Enterprises,
— Experience in Design and development of medical device products,
— Capabilities to develop, build & test prototype devices,
— Manufacture, assembly and packaging capabilities in-house,
— Capability to carry out/manage medical device biocompatibility testing,
— Experience in compiling and submitting for regulatory approval of Class II and Class III medical devices, CE Mark and FDA approval,
— Quality Assurance, inspection and testing capabilities in-house.

Deadline

The time limit for receipt of tenders was 2013-10-24. The procurement was published on 2013-09-19.

Who? What? Where?
Procurement history
Date Document
2013-09-19 Contract notice
Contract notice (2013-09-19)
Object
Scope of the procurement
Title: Miscellaneous medical devices and products
Quantity or scope: See pre qual.240 000
Total value of the procurement: 240 000 💰
Notice metadata
Original language: English 🗣️
Document type: Contract notice
Nature of contract: Services
Regulation: European Union
Common procurement vocabulary (CPV)
Code: Miscellaneous medical devices and products 📦

Procedure
Procedure type: Restricted procedure
Type of bid: Submission for one or more lots
Award criteria
Lowest price

Contracting authority
Identity
Country: Ireland 🇮🇪
Awarding authority type: Body governed by public law
Awarding authority name: Cork Institute of Technology
Postal address: Rossa Avenue, Bishopstown
Postal town: Cork
Contact
E-mail: catherine.cunningham@cit.ie 📧
Phone: +353 214335033 📞
Fax: +353 214335031 📠

Reference
Dates
Date dispatched: 2013-09-19 📅
Submission deadline: 2013-10-24 📅
Publication date: 2013-09-21 📅
Identifiers
Notice number: 2013/S 184-318047
OJ-S issue: 184
Additional information
To receive more information about this tender, including any amendments and/or clarifications and to request any clarifications and/or to respond to this tender, you must register your interest to this tender on the following site: https://irl.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=70310&B=ETENDERS_SIMPLE
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Object
Scope of the procurement
Short description:
CIT requires a suitably qualified medical device manufacturer which the capability and capacity to manufacture product to the Institute's specific requirements and to work with it to achieve CE marking and FDA approval for this medical device.
The intention will be to place Applicants that demonstrate their capability and capacity to meet CIT's needs on a Framework Agreement. During the life of that Agreement, when CIT has a developed product which it believes is ready for volume manufacture and regulatory submission, CIT will invite all those Applicants admitted to the Framework Agreement to submit tender for that opportunity.
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It is anticipated that Applicants admitted to the Framework Agreement will meet the following requirements:
— A Medical Device manufacture with a validated clean-room facility to class 10,000,
— Have an accredited Quality Management System to ISO 13485 for Medical Device Manufacture,
— An accredited Quality Management System to cover Design Control would be advantageous,
— Experience in working with Institute of Technology on Enterprise Ireland Commercialisation Funds or experience with Start-Up Enterprises,
— Experience in Design and development of medical device products,
— Capabilities to develop, build & test prototype devices,
— Manufacture, assembly and packaging capabilities in-house,
— Capability to carry out/manage medical device biocompatibility testing,
— Experience in compiling and submitting for regulatory approval of Class II and Class III medical devices, CE Mark and FDA approval,
— Quality Assurance, inspection and testing capabilities in-house.
Lot number: 1
Title of the lot: Framework Agreement for the Medical Device manufacture, assembly, packaging
Estimated value excluding VAT: 150 000 💰
240 000 💰
Quantity or scope: See pre qual.
Duration: 12 months

Legal, economic, financial and technical information
Contract execution
Deposits and guarantees required: n/a

Procedure
Maximum number of operators of the framework agreement: 5
Duration of the framework agreement in years: 2
Minimum number of candidates: 2
Maximum number of candidates: 5
Objective criteria for selection: Only a few tenders being run after the framework is established.
Date of dispatch of invitations: 2013-12-02 📅

Contracting authority
Contact
Contact point: Catherine Cunningham
Source: OJS 2013/S 184-318047 (2013-09-19)
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