Dr. Grömping Consulting

EU MDR IVDR FDA Clinical Evaluation

Dr. Grömping Consulting is the independent German practice of Andreas Grömping, based in Rosendahl. Drawing on medical-device industry and notified-body experience, he advises on EU MDR and IVDR compliance, technical documentation, quality management, risk analysis and post-market surveillance. His services also cover clinical and IVD performance evaluation, clinical investigations, usability, biocompatibility and international market access, including FDA 510(k) and De Novo pathways.

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