|Cavis Technologies AB
|Funding from Vinnova
|SEK 200 000
|April 2017 - March 2018
|Medtech4Health: Competence Enhancement in SME
Purpose and goal
The goal was to strengthen the development team so that it is possible to start clinical use of our innovative catheter.
Expected results and effects
We have developed a quality system for the company that has been preaudited by our notified body in February 2018 with good results. Verification and validation of process and design has been carried out in large part during the winter 2017-2018. Submission of technical documentation for review by our Notified Body is planned during 2018.
Planned approach and implementation
The aim of the project was to strengthen the company with regulatory competence so that CE marking can be obtained. We have hired an expert who did the major part of the regulatory work and succeeded well with this task. CE marking was not achieved within the time frame of the project as originally planned. Overall, however, we consider the skills gain project as very successful, since a major part of the regulatory work has been finalized within the project.