Regulatory assistance in preparation for CE mark
| Reference number | |
| Coordinator | TADA MEDICAL AB |
| Funding from Vinnova | SEK 115 700 |
| Project duration | November 2019 - October 2020 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The purpose and goal of the project have been fulfilled well. Some delay due to the prevailing pandemic has been handled effectively to minimize the impact on the project. Testing is completed or planned to be completed within the coming weeks. The technical file is under construction and is planned to be completed in connection with the final test results coming in within a few weeks.
Expected results and effects
The project result has exceeded our expectations. Despite the current circumstances, we have managed to go through with, or book, all necessary test needed for an approved CE mark. Two individuals from the company has successively been trained during the project to be able to pick up where the expert consultant leaves off. This is a great boost with regards to time- and cost efficiency for the company. The acquired knowledge will be used within the near future in a newly started project.
Planned approach and implementation
The project started with a planning phase where the project and the product were evaluated and a plan for all testing and documentation needed for a CE approval was put in place. Testing and analysis of test data has been performed continuously throughout the project. Because of the pandemic, some tests had to be postponed, these are however planned to be done over the coming weeks. The technical file is as good as finalised and will be so with the addition of the results from the final tests. CE audit is booked for December 2020.