During the initial discussion of the regulation, an initial, very rough analysis of the requirements was carried out. The subsequent kickoff meeting on the subject of EU MDR with all the departments involved met with a great response and created a common awareness of the scope within the departments and management. Under the direction of the project manager, the cross-functional team evaluated all requirements and derived appropriate measures for implementation. This also resulted in strategic questions regarding the product range and the organizational structure. For example, the project team considered whether the continuation of an affected product line was still economically viable. The constant restructuring of the company and the bridging to parallel running development projects posed an additional challenge.

Through targeted communication, all information relevant to the project could be provided and conflicts avoided at an early stage. In addition, the necessary tools for planning were compiled from the available system and supplemented by our own methods for stakeholder and requirements analysis.