Knowledge for FDA application
| Reference number | |
| Coordinator | Interlinked AB |
| Funding from Vinnova | SEK 89 391 |
| Project duration | October 2024 - April 2025 |
| Status | Ongoing |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in Small Businesses 2024 |
Important results from the project
The goal of the project was to update the company´s technical documentation and quality management system to meet regulatory eligibility requirements from the FDA. The project has progressed according to plan and the company has now expanded its knowledge portfolio in a very important way.
Expected long term effects
The project´s results will, in the long term, open up one of the world´s most valuable and homogeneous markets for the company and its medical device product.
Approach and implementation
The project has been carried out by a regulatory expert who has transferred his knowledge by, together with employees from the company, carrying out analyses and updates, developing test plans, and creating a proposal. The work packages that were initially set have been implemented as intended. Some tests have taken longer time than expected to get the results, but otherwise everything has flown along.