Competence enhancement within quality management system for the transition to MDR

Purpose and goal

** Denna text är maskinöversatt ** The purpose of the project is to expand PU sensor´s internal competence in quality management systems and to carry out the transition to MDR.

Expected effects and result

** Denna text är maskinöversatt ** The expected result is a fully implemented quality management system, that all personnel are trained in the system and documentation for the transition of PU sensor to MDR.

Planned approach and implementation

** Denna text är maskinöversatt ** * Workshops for the development of the quality management system so that it meets 13485 * Full implementation of the quality management system * Gap analysis and documentation to enable the transition of the product to MDR * Utbildning both for QA and for all personnel