Clinical and Regulatory Competence Reinforcement in Novosense AB
| Reference number | |
| Coordinator | Novosense AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | October 2020 - October 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
From the autumn of 2020 until October 2021, Novosense has implemented the project "Clinical and Regulatory Competence Strengthening in Novosense AB". The overall goal of the project has been to increase the competence of the company and the staff regarding clinical and regulatory expertise. The project has been carried out in connection with the company´s clinical trial and work with CE marking of the company´s wireless ECG product.
Expected long term effects
The project " Clinical and Regulatory Competence Strengthening in Novosense AB" has delivered the expected outcome, albeit somewhat delayed. The delay is due to COVID and related problems.
Approach and implementation
The following activities were identified as most relevant to the project. - Initiation of clinical trial with Monitor - Training of test staff on the test product - Continuous testing of CardioSenseSystem - Database cleaning and database lock, Regulatory expert - Close-out, Monitor - Regulatory documentation, Regulatory expert and Monitor Necessary skills are listed to the right of the activity