Digital platform for multiparametric diagnostic tests - step 2
| Reference number | |
| Coordinator | Oncoalgorithms AB |
| Funding from Vinnova | SEK 900 000 |
| Project duration | January 2019 - March 2020 |
| Status | Completed |
| Venture | Innovative Startups |
Purpose and goal
The project has resulted in a much stronger company. Oncoalgorithms has started the certification process according to ISO 13485, develops a new multi-parametric IVD product in prostate cancer, and has found a good relationship with a very large customer.
Expected results and effects
New multiparametric diagnostic tests (MPDT) have been investigated. We have even started producing one, and are planning to launch this summer (despite COVID-19). Control samples have been examined and developed. We now have a panel of statistically designed control samples for an MPDT. Quality assurance and documentation for ISO13485 certification are in process. Certification consists of two steps. Step one is completed with minimal remarks and step two is scheduled for June (but may be postponed)
Planned approach and implementation
Since Oncoalgorithms works according to quality assured processes, the project has been carried out in accordance with these. For example: Review of technical and design conditions has involved discussions with users / customers to collect product requirements which are then translated into technical specifications in the life cycle planning of the intended product. All according to ISO 13485. The most important lesson is to strategically choose where in the documentation you can be word-rich and where you have to be careful not to create side effects in adjacent documentation.