An initial, very rough analysis of the requirements was carried out during the initial discussion of the regulation. The subsequent kick-off meeting on the topic of EU MDR with all departments involved met with a great response and created a shared awareness of the scope within the departments and management. Under the supervision of the project manager, the cross-functional team assessed all requirements and derived appropriate measures for implementation. This also gave rise to strategic questions regarding the product range and 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 of parallel 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.