ZTX-PREDICT is a new tool that predicts the right treatment for the right patient within 5 days
| Reference number | |
| Coordinator | BioReperia AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | August 2020 - July 2021 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
The purpose of the project was to analyze BioReperias at that time existing QMS and identify changes that needed to be implemented to allow regulatory approval of BioReperias products. The work was concluded in 2020. The work on implementing the identified changes has started and is expected to finish with the submission for approval of our QMS and CE-application in Q1 2022.
Expected long term effects
The project resultet in extensive changes in the quality processes at BioReperia, which greatly elevated the level of both the quality work on an every day basis as well as the systems that regulate this work. We gained a deeper understanding of quality and regulatory aspects of our product, and is now working with these issues in a much better way, being fully compliant with international standards. As a result we now realize what we need to do to get our innovative ZTX-Predict product on the market, and we have a regulatory plan that will help us to succeed with this goal.
Approach and implementation
The way the work was planned in this project, including close collaboration, workshops and practical hands-on transfer of knowledge and kompetense has worked well for us. Considering that our new employee (Elinore) needed to be inserted into the processes, larger efforts and more time than originally planned was needed, but the execution of these extra efforts have been necessary for us to come as far as we have in our regulatory work.