Project for FDA approval for Swedish Novel Artficial Heart
| Reference number | |
| Coordinator | Scandinavian Real Heart AB |
| Funding from Vinnova | SEK 198 636 |
| Project duration | April 2020 - September 2020 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
The purpose was to strengthen SRH´s international competitiveness, strengthen women´s influence in SRH through the development of specialist competence, and to anchor the competence in the company in the long term in the area of regulatory development with the help of documented test protocols. The goal of training the management, guiding the company in establishing a quality management system, and writing a Pre-Submission report has been achieved. Final review and submission to the FDA remains. The project participants´ new skills are of great benefit to them and the company.
Expected long term effects
The results include a Pre-submission report including appendices for submission to the FDA, as well as new knowledge from the project participants. SRH has some questions for the FDA regarding the test strategy, and communication with the FDA means that these queries will be clarified. The expected effects are increased test productivity and a more cost-effective use of test resources. Publication of blood test results in international scientific journals is expected to increase customers´ recognition of Realheart´s brand and create new opportunities to find partners.
Approach and implementation
The arrangement that SRH carried out most of the work with support from M Cook worked extremely well. It provided time for reflection and learning for SRH´s staff in the work of revising the documents according to M Cook´s suggestions and queries. The resulting documents will be able to be used as templates in future communications with the FDA. In this way, the knowledge lives on and is propagated in future projects.