Deveopment of project plan and technical file in accordance with MDR and ISO13485 for a surgical sewing machine
| Reference number | |
| Coordinator | Suturion AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | December 2020 - May 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
In order to continue to have a clear and cohesive project structure, we sought funding for a project assistant. The project assistant´s responsibility was to develop plans for the regulatory activities and ensure that Suturion had a sustainable and clear project structure.
Expected long term effects
We have developed a project plan with regulatory and technical activities that extend to CE marking. We have a clear project structure with project meetings and cloud-based documentation. Proper and documentation and documentation structure according to the quality system is crucial for CE marking and FDA approval which is necessary for market entry
Approach and implementation
The project aimed to produce a project plan in accordance with MDR and ISO13485 as well as a structure for technical file and integrate a sustainable project work structure in Suturion´s work. The documentation that has been produced follows the regulatory plan and the weekly meetings have been given a clear structure and we have been given a clear report structure for board meetings. Standing project meetings provide good insight into the project participants´ work and challenges.