Pilot study for MDR/CE mark

Purpose and goal:

The goal of the project was to start the process for compliance according to the MDR and create knowledge in our organization about the eligibility requirements

that are set for a CE marking. The project proceeded according to plan and provided good insights and basis for future strategic decisions. Expected results and effects: The project defined intended use of the service as well as qualification and classification within compliance for MDR.

The project delivered a complete GSPR checklist with identified activities, a started summary of technical documentation for MDR/CE certification and project plan for future work. The project has provided a greatly increased competence in MDR/CE marking in the organization. Approach and implementation:

Compilation of information about the product, processes and organization before start-up Start-up including meeting, time for introduction Qualification, classification and plan for activities. Define intended use and intended users for the product In-depth analysis and produces the necessary data to start

implementation/creation of the technical documentation required for CE marking. First version of Technical Documentation (TD) Summary and a GSPR checklist Project plan for a CE marking project