Support with technical documentation for diagnostic tests in pancreatic cancer

Important results from the project

** Denna text är maskinöversatt ** Reccan aims to improve the prognosis of pancreatic cancer patients by launching a new diagnostic test. The project focuses on strengthening the company´s competence in regulatory areas to meet the requirements for IVD products and certification. Important regulatory documents have been created to ensure that technical documentation is in phase with the project, which was the goal that is considered well met.

Expected long term effects

** Denna text är maskinöversatt ** Through the project and the expert support, the company´s internal competence in the regulatory area increased. The key people can now independently carry out a similar project. The project resulted in technical documents ready for notified body review as well as templates for the remaining documents. The collaboration has strengthened the organization and enabled future independent project and skills exchange.

Approach and implementation

** Denna text är maskinöversatt ** During the project´s initial phase, the company´s objective and challenges related to the regulatory work were presented so that the expert would get a good idea of the company´s product and challenges. Afterwards, the need for support and which areas should be prioritised were mapped out together. The writing of the technical documents was carried out together.