Framework Agreement for Medical - Framework Agreement for the Medical Device manufacture, assembly, packaging
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?
Procurement history
| Date |
Document |
| 2013-09-19
|
Contract notice
|