Catheasy - urinary catheterization for reduced infections in health care
| Reference number | |
| Coordinator | CATHEASY VÄSTERÅS AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | May 2016 - October 2016 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in SME - 2016 |
Important results from the project
The purpose of the project was to provide the right setting for theCE certification process of the company´s medical device.The objective was to utilize external competence to set up the technical file and to prepare the product and the company for CE certification. This project has reached its objective and even started the CE certification process with notified body.
Expected long term effects
Activities and documentation regarding clinical validation, product expiry, technical file, design transfer and quality system has successfully been performed during this project.This has resulted in that the CE certification process has been initiated and CE certification is expected by the end of Q1 2017.
Approach and implementation
By being able to add the specific competence and knowledge needed regarding regulatory and practical CE certification the company has had access to individuals that could describe, plan and lead the activities and documentation process necessary for the CE process. By having the relevant competence for the preparation of the CE documentation and process a CE certification has been made possible in an effective way.