Quality work under MDR - a competence development project

Purpose and goal:

The goal of the project was to establish and implement a Quality Management System (QMS) for medical devices, as well as increase the personnel´s competence in quality management. The purpose of this, is for the company to maintain a well-functioning QMS, in line with the legal, regulatory requirements after project completion.

Expected results and effects:

Thanks to the project, the company´s competence in quality management work has increased significantly, and it now has established methods that ensure that all employees perform all steps in a coordinated and controlled manner. The goal has been met and the project has both contributed to increasing the company´s internal competence and, strengthened the company´s market competitiveness.

An expected effect is higher quality and better control of the company´s internal processes and its medical devices. Approach and implementation:

Under the consultant´s guidance, the team has established a number of controlled procedures based on ISO standard 13485 Medical devices - Quality management systems - Requirements for regulatory purposes. Reconciliation meetings were held weekly where new procedures were reviewed and discussed. The consultant led the work with the procedures to be established.

The PressCise team was responsible for adapting these to the company´s activities and its products. All procedures were reviewed and signed by the entire project team. The working method has worked very well and structured.