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Marianna Mastroroberto, NB 0476

Clinical Expert Manager
Kiwa Cermet Italia
Bologna, Emilia-Romagna, Italy

Dr. Marianna Mastroroberto is a physician and regulatory affairs professional specializing in the clinical evaluation of medical devices under Regulation (EU) 2017/745. She combines direct clinical experience in hospital and community care with academic research in clinical medicine, where she also refined her expertise in biostatistics. This background enables her to approach regulatory challenges with an evidence-based perspective, bringing the clinician’s voice into a field where medical expertise is not yet fully integrated.

In recent years, Dr. Mastroroberto has served as a clinical evaluator and clinical manager within several Notified Bodies during the transition from MDD to MDR. This role has allowed her to support manufacturers across diverse device categories, applying a holistic approach that merges clinical experience, technical competence, regulatory interpretation, communication, and strategic vision. She has also contributed to improving internal processes and integrating clinical expertise into certification workflows.

She regularly participates in international conferences, training events, and institutional technical tables, sharing insights on clinical evaluation and MDR implementation. Through this work, she is committed to advancing regulatory science and bridging the gap between clinical practice and regulatory affairs.

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