Implementation of quality management system for CE/FDA

Purpose and goal

Medical device products must follow the regulatory demands that are set by authorities for use in clinical diagnostics. A CE mark and a FDA approval is a prerequisite for clinical usage in Europe and the US respectively. To file for approval a Quality Management System needs to be implemented in the company that describes the product development activities and procedures. We have during the project implemented the obligatory parts of a Quality Management System to be able to go through with clinical validation.

Expected results and effects

During the project we have created an efficient Quality Management System constructed to fit the company´s operations and follow the relevant ISO standards at the same time. This system will be the foundation for how we perform future product development and to support documentation for CE mark and FDA application. We will is this way have a competitive advantage compared to our competitors and enable revenues from sales to hospitals.

Planned approach and implementation

The project was divided in three parts. In step 1 we investigated and planned how the system would be set up and documented. Step 2 included documentation of the product development process. This was the most important step. 1928 staff and consultants from Qing worked side by side to describe the processes and procedures of product development. In step 3 the Quality Management System was finalised and a first draft could be signed off. The system will of course go through many updates during coming years and also complemented with procedures that are not relevant at this point.