CE-marking of Class IIa medical device

Important results from the project

** Denna text är maskinöversatt ** The competence enhancement aims to enable Geras Solutions to reach a class IIa CE-certifiering in line with future legislation (MDR). The work entails further development and documentation of quality management systems and technical file.

Expected long term effects

** Denna text är maskinöversatt ** The project has been completed successfully and the goals have mainly been completed. - Documented processes implemented / validated working method. - Strengthened general level of knowledge - Dedicated quality manager on site - Prepared process with notified bodies

Approach and implementation

This project was carried out to ensure access to justice competence to be able to obtain the correct CE marking after an audit is performed by a notified body. External support was successfully engaged for guidance in the work with preparations for CE marking as well as ongoing support for the new role as Gera´s quality manager. The external consulting support has acted as a coach, advisor and training partner in medical technology regulatory requirements must have been a success factor in establishing the role and developing the content into technical file and QMS.