News & Projects

Through certification to the market

Fund name: European Fund for Regional Development
Project name: "Comby EEG caps on the US market with FDA certificate – KK.03.2.1.0080"
Beneficiary: Pamel d.o.o.
Project summary: The subject of this project is the preparation of documentation for successfully obtaining 510(k) Approval from the US Food and Drug Administration (FDA) for the Applicant's products: EEG Caps, Electrodes and accessories. The result of the project is a technical file that accompanies the 510(k) Approval that the FDA requires in order for a medical device to be commercially distributed on the US market, and has a very similar purpose to the CE mark in Europe. The project also invests in the process of applying for 510(k) approval, the activities of harmonizing the documentation of the technical file after the application to the FDA, and in all the necessary product testing.
General goal of the project: By fulfilling the specific goal, the general goal will be achieved: the growth of SMEs on regional, national and international markets will be stimulated through the increased application of norms, together with a reliable technological solution, thus providing a prerequisite for increasing exports and the overall competitiveness of SMEs. An internationally recognized norm will be introduced, thus contributing to SMEs taking advantage of the advantages that the application of norms has for enabling access to new markets.
Specific project objectives: The applicant meets the demand for the COMBY EEG CAP in the US market, but without FDA 510(k) Approval is unable to market the product. That is why the goal of the project, through the increased application of standards, together with a reliable technological solution, is to prove the specific quality, safety, simplicity and reliability of its products through the activities of the project and to ensure the prerequisites for increasing exports and overall competitiveness.
Project implementation period: December 31, 2019 – September 30, 2021
Contact person: Marko Pavić
Relevant links: www.strukturnifondovi.hr

Support for medical product manufacturing

Fund name: European Fund for Regional Development
Project name: "Support for medical product manufacturing"
Project summary: The beneficiary independently and in cooperation with professional institutions developed several products for the needs of neurophysiology, psychophysiology, physical medicine and rehabilitation. The specific goal of the project was to eliminate existing deficiencies and expand the capacities of the existing business unit. The main elements of the project were: defining the technical requirements of the tools, preparing documentation, conducting procurement procedures, purchasing and installing production tools and a heating/cooling system for the business premises.
Goals and expected results: Four new tools installed and put into operation in the beneficiary's workshop; heating/cooling system installed and put into operation. This will result in the production of products with higher technological requirements and an increase in the product range, as well as enabling further compliance with the requirements of medical standards in production and creating more appropriate working conditions.
Total project value and EU co-financing: Total project value: 513,134.48 HRK; EU co-financing: 300,000.00 HRK
Project implementation period: September 18, 2017 – March 18, 2018
Contact person: Marko Pavić
Relevant links: www.strukturnifondovi.hr